- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00281879
Donor Stem Cell Transplant or Donor White Blood Cell Infusions in Treating Patients With Hematologic Cancer
Transplantation of Unrelated Donor Hematopoietic Stem Cells for the Treatment of Hematological Malignancies
RATIONALE: A peripheral stem cell transplant or an umbilical cord blood transplant from a donor may be able to replace blood-forming cells that were destroyed by chemotherapy or radiation therapy. Giving an infusion of the donor's white blood cells (donor lymphocyte infusion) after the transplant may help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells can make an immune response against the body's normal cells. Methotrexate, cyclosporine, tacrolimus, or methylprednisolone may stop this from happening.
PURPOSE: This clinical trial is studying how well a donor stem cell transplant or donor white blood cell infusions work in treating patients with hematologic cancer.
Study Overview
Status
Conditions
Intervention / Treatment
- Biological: filgrastim
- Drug: cyclophosphamide
- Drug: cyclosporine
- Drug: methotrexate
- Drug: mycophenolate mofetil
- Drug: tacrolimus
- Procedure: peripheral blood stem cell transplantation
- Radiation: radiation therapy
- Drug: busulfan
- Drug: carmustine
- Drug: cytarabine
- Drug: etoposide
- Drug: melphalan
- Drug: fludarabine phosphate
- Biological: anti-thymocyte globulin
- Drug: methylprednisolone
- Procedure: umbilical cord blood transplantation
Detailed Description
OBJECTIVES:
Primary
- Determine the effectiveness of unrelated donor allogeneic hematopoietic stem cells for transplantation after conditioning for the treatment of patients with high-risk hematologic malignancies.
- Compare survival, disease-free survival (DFS), response rate, and toxicity rates in these patients with historical controls.
- Compare the rate and severity of acute and chronic GVHD after allogeneic hematopoietic stem cell transplantation in patients with hematopoietic malignancies with historical controls transplanted with stem cells from related sibling donors
- Assess engraftment, long-term hematopoietic recovery, relapse rate, and disease-free survival when allogeneic hematopoietic stem cells are used as a source of stem cells for transplantation in patients with high-risk hematological malignancies.
- Assess engraftment, long-term hematopoietic recovery, and overall survival when allogeneic hematopoietic stem cells are used as a source of stem cells for transplantation in patients who have graft failure or graft rejection.
- Compare engraftment, long-term hematopoietic recovery, rate of GVHD, rate of relapse, toxicity rates, overall disease-free survival and overall survival when donor leukocyte infusions (DLI) are given for patients who have disease recurrence, progression, or low donor chimerisms after unrelated stem cell transplantation or before DLI with historical controls of other donor leukocyte infusions.
Secondary
- Determine the quality of life of patients undergoing hematopoietic stem cell transplantation or donor leukocyte infusions from unrelated HLA genotypically-identical donors.
OUTLINE: Patients are assigned to 1 of 8 treatment groups.
- Group 1*: Patients undergo total body irradiation (TBI) twice a day on days -7 to -4. Patients then receive cyclophosphamide IV over 1 hour on days -3 and -2. On day 0 patients undergo stem cell transplantation (SCT). Beginning on day 7, patients receive filgrastim (G-CSF) IV once daily until blood counts recover.
- Group 2 (patients who have previously experienced dose-limiting radiotherapy): Patients receive oral busulfan 4 times daily on days -7 to -4 and cyclophosphamide IV over 1 hour on days -3 and -2. On day 0 patients undergo SCT. Beginning on day 7, patients receive G-CSF IV once daily until blood counts recover.
- Group 3 (pediatric patients only): Patients receive busulfan IV 4 times daily on days -9 to -6 and cyclophosphamide IV over 1 hour and fludarabine IV over 30 minutes on days -5 to -2. On day 0 patients undergo SCT. Beginning on day 7, patients may receive G-CSF IV once daily until blood counts recover.
- Group 4 (second SCT for patients who have experienced graft rejection or failure)*: Patients receive low-dose fludarabine IV over 30 minutes on days -4 to -2. Patients then undergo low-dose TBI once followed by SCT on day 0. Beginning on day 7, patients may receive G-CSF IV once daily until blood counts recover.
- Group 5 (patients who developed grade 3 cystitis after prior cyclophosphamide-containing therapy): Patients receive carmustine IV over 2 hours on day -6, etoposide IV over 2 hours and cytarabine IV over 30 minutes on days -5 to -2, and melphalan IV over 30 minutes on day -1 (BEAM). On day 0, patients undergo SCT. Beginning on day 7, patients receive G-CSF IV once daily until blood counts recover.
- Group 6 (cord blood transplantation): Patients receive anti-thymocyte globulin IV once daily and methylprednisolone IV twice daily on days -3 to -1. On day 0, patients undergo an umbilical cord blood SCT.
- Group 7 (patients with relapsing or progressive disease after prior transplants or low donor chimerisms)*: Patients must not have existing graft-versus-host disease (GVHD). Patients receive donor lymphocyte infusions with conditioning chemotherapy and/or radiotherapy at the discretion of the investigator.
- Group 8 (pediatric patients only)*: Patients undergo TBI twice a day on days -7 to -5. Patients also receive etoposide IV over 24 hours on day -4 and cyclophosphamide IV over 1 hour on days -3 and -2. On day 0, patients undergo SCT. Beginning on day 7, patients may receive G-CSF IV once daily until blood counts recover.
NOTE: *Patients who have received > 3000 cGy to the central nervous system or > 2000 cGy to the lung or liver may not receive any regimen containing total body irradiation (TBI)
All patients receive GVHD prophylaxis comprising methotrexate IV on days 1, 3, 6, and 11; cyclosporine and/or tacrolimus on days -2 to 100; and/or methylprednisolone IV on days 7 to 100.
Patients with an unrelated donor who experience a relapse prior to transplantation, may proceed directly to transplantation. However, if immediate transplantation from the unrelated donor is not possible, the patient must be re-induced into a complete hematological remission. Patients who experience graft failure or graft rejection after allogeneic transplantation are eligible for a second stem cell infusion from the original donor.
Quality of life is assessed at baseline and at 7 days, 3 months, and 1 year after transplantation.
After completion of study treatment, patients are followed periodically for survival.
PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97239-3098
- OHSU Knight Cancer Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following*:
Acute lymphoblastic leukemia in any disease phase
Patients with any of the following high-risk features are encouraged to enroll:
- Philadelphia chromosome positive disease
- L3 morphology, especially in the presence of t(8;14), t(8;22), or t(2;8)
- Patients not in remission at day 28 of first induction
- High LDH (i.e., ≥ 300 IU/mL at presentation)
- Pre-B-cell, mixed lineage, or Burkitt's markers
- Relapsed in the marrow while receiving continuous chemotherapy
- Within 6 months after stopping chemotherapy
- Relapse in one organ or extramedullary relapses in more than one organ while still receiving chemotherapy
Hodgkin's or non-Hodgkin's lymphoma beyond first complete remission (CR) or in first CR with features of high-risk disease, including, but not limited to:
- Lymphoma not in CR after 3 courses of primary therapy
- Patients with bulky disease at presentation, especially bulky mediastinal disease
- Patients with LDH ≥ 300 IU/mL at presentation
- Patients with extranodal disease
- Patients with first remission within less than 1 year
- Stage IV disease at presentation, especially with marrow involvement
- Patients with high-intermediate or high International Index Scores
Acute myeloid leukemia (AML) meeting the following criteria:
- Beyond first remission or high-risk disease in first CR
- Required multiple courses of induction therapy to achieve a remission
- Had residual leukemia on day 14-28 bone marrow examination after initial induction
- Patients with any cytogenetic abnormality except inv 16 or t(8;21)
Chronic myelogenous leukemia in the chronic or early accelerated phase of the disease
- Patients with blast crisis that can be induced back into chronic phase may be transplanted in second chronic phase
Myelodysplastic syndromes (MDS) meeting the following requirements:
- Transfusion-dependent refractory anemia (RA), RA with excess blasts (RAEB), RAEB in transformation, or chronic myelomonocytic leukemia (CMML)
- Patients with MDS that present with or evolve to AML must be re-induced back to remission prior to initiating a search for an unrelated donor NOTE: *Patients with other hematologic malignancies not listed above, including diseases such as chronic lymphocytic leukemia (CLL), multiple myeloma, or rare pediatric malignancies, or patients who are felt to be at high-risk for relapse but who do not have features listed, may be allowed at the discretion of the investigator.
- Must have failed prior stem cell transplantation
Must have a suitable unrelated allogeneic hematopoietic stem cell donor
- A 5/6 match degree is acceptable for unrelated bone marrow donors
- A 4/6 match degree is acceptable for unrelated cord blood units
PATIENT CHARACTERISTICS:
- SWOG performance status (PS) 0-2 OR
- Karnofsky PS 50-100% OR
- Lansky PS 50-100%
- Creatinine clearance ≥ 45 mL/min
- Creatinine ≤ 2.5 mg/dL
- Bilirubin ≤ 2 mg/dL (abnormally high liver function tests allowed if the only source for the elevation is due to lymphoma of the liver)
- AST or ALT ≤ 2 times normal (abnormally high liver function tests allowed if the only source for the elevation is due to lymphoma of the liver)
- No patients at high risk of veno-occlusive disease
- Not pregnant or nursing
- Negative serum pregnancy test
- Fertile patients must use an effective contraceptive method
- DLCO ≥ 50% of predicted
- FEV_1/FVC ≥ 65% of predicted
- No current congestive heart failure (CHF) and/or LVEF ≥ 45%
- No myocardial infarction within the past 6 months
- No unstable angina within the past 6 months
- HIV negative
- Life expectancy must not be limited by disease other than malignancy
- No allergy to any chemotherapeutic agent included in the regimen
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Cyclophosphamide (Cytoxan) and Total Body Irradiation (TBI)
|
Will be given IV at 5 µg/kg/day. The first injection will be administered on day +7, i.e. 7 days after the hematopoietic stem cells are infused. Will be administered until the ANC is 1500 / µl for 2 days. Dose and schedule of G-CSF administration is left to each center's discretion.
Other Names:
For transplantation, the drug is diluted in 250 to 500 cc of NS or D5W and administered IV over 2 hours.
Initial doses will be administered IV at a starting dose of 1.5 mg/kg BID.
The infusion will vary from 2-24hr depending on the incidence of side-effects.
Administered on days +1, +3, and +7.
Mycophenolate may be used as a substitute for Methotrexate
A drug used to decrease the risk of graft versus host disease (GvHD).
Other Names:
The stem cells will be given to you by intravenous injection (through your vein) using a catheter that was placed prior to beginning chemotherapy.
The stem cell infusion takes 1-6 hours.
Radiation will be given to you 2 times a day for 3 or 4 days.
|
Active Comparator: Busulfan and Cyclophosphamide (Cytoxan)
|
Will be given IV at 5 µg/kg/day. The first injection will be administered on day +7, i.e. 7 days after the hematopoietic stem cells are infused. Will be administered until the ANC is 1500 / µl for 2 days. Dose and schedule of G-CSF administration is left to each center's discretion.
Other Names:
For transplantation, the drug is diluted in 250 to 500 cc of NS or D5W and administered IV over 2 hours.
Initial doses will be administered IV at a starting dose of 1.5 mg/kg BID.
The infusion will vary from 2-24hr depending on the incidence of side-effects.
Administered on days +1, +3, and +7.
Mycophenolate may be used as a substitute for Methotrexate
A drug used to decrease the risk of graft versus host disease (GvHD).
Other Names:
The stem cells will be given to you by intravenous injection (through your vein) using a catheter that was placed prior to beginning chemotherapy.
The stem cell infusion takes 1-6 hours.
Patients who take the drug PO, busulfan will be administered at 1 mg/kg/ dose given by mouth every 6 hours for 16 consecutive doses.
Pediatric patients who receive busulfan IV continuous infusion will receive a dose of 3.0 mg/kg/IBW if under the age of 2.Pediatric patients over the age of 2 will receive busulfan at a dose of 0.8 mg/kg/dose.
|
Active Comparator: BEAM Regimen
On the day of your admission, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI.
Chemotherapy will begin on Day -6 with carmustine (BCNU), followed by etoposide (VP-16), cytosine arabinoside (ARA-C), and melphalan.
This conditioning regimen is known as the BEAM regimen.
The dose of this therapy is high enough to kill cancer cells but will also kill all of your normal blood forming cells.
Subjects undergoing the BEAM regimen will not have total body irradiation (TBI).
|
Will be given IV at 5 µg/kg/day. The first injection will be administered on day +7, i.e. 7 days after the hematopoietic stem cells are infused. Will be administered until the ANC is 1500 / µl for 2 days. Dose and schedule of G-CSF administration is left to each center's discretion.
Other Names:
Initial doses will be administered IV at a starting dose of 1.5 mg/kg BID.
The infusion will vary from 2-24hr depending on the incidence of side-effects.
Administered on days +1, +3, and +7.
Mycophenolate may be used as a substitute for Methotrexate
A drug used to decrease the risk of graft versus host disease (GvHD).
Other Names:
The stem cells will be given to you by intravenous injection (through your vein) using a catheter that was placed prior to beginning chemotherapy.
The stem cell infusion takes 1-6 hours.
300mg/m2 IV dissolved in 500 cc NS infused over 2 hours into right atrial catheter on day -6.
400 mg/m2 dissolved in 200cc D5W and infused over 30 minutes into right atrial catheter on days -5, -4, -3, -2.
Etoposide administration 200 mg /m2 dissolved in 1 liter NS and infused over 2 hours into right atrial catheter. Infusion to begin after cytarabine administration on days -5, -4, -3, -2. Etoposide administration 50 mg/kg IV over 24 hours, divided into 3 doses. Dilute in normal saline at a concentration of 0.4 mg/ml (Observe for precipitation). Administered IV with continuous infusion over 24 hours. Diuretics may be given for fluid overload.
140 mg /m2 in concentration of 0.45 mg/ml of NS infused over 30 minutes into right atrial catheter on day -1.
|
Active Comparator: Low-Dose Fludarabine and TBI(for second stem cell donation)
A conditioning regimen of low-dose fludarabine and TBI is used in the event that a second donation of hematopoietic stem cells is necessary.
Chemotherapy with Fludarabine will begin 4 days prior to your transplant.
This drug will be given through the catheter in your chest daily for 3 days.
TBI (radiation) will be given to you on the day of your transplant.
After your TBI, your donor's stem cells / bone marrow will be given to you through your catheter.
The drugs cyclosporine and mycophenolate mofetil (MMF) will be given orally to help you accept your donor's cells.
|
Will be given IV at 5 µg/kg/day. The first injection will be administered on day +7, i.e. 7 days after the hematopoietic stem cells are infused. Will be administered until the ANC is 1500 / µl for 2 days. Dose and schedule of G-CSF administration is left to each center's discretion.
Other Names:
Initial doses will be administered IV at a starting dose of 1.5 mg/kg BID.
The infusion will vary from 2-24hr depending on the incidence of side-effects.
Administered on days +1, +3, and +7.
Mycophenolate may be used as a substitute for Methotrexate
A drug used to decrease the risk of graft versus host disease (GvHD).
Other Names:
The stem cells will be given to you by intravenous injection (through your vein) using a catheter that was placed prior to beginning chemotherapy.
The stem cell infusion takes 1-6 hours.
Radiation will be given to you 2 times a day for 3 or 4 days.
Fludarabine administered at 30 mg/m2 IVPB infused over 30 minutes into right atrial catheter on days -4, -3, -2. Fludarabine administered at 40 mg/m2 IVPB infused over 30 into the right atrial catheter on days -5, -4, -3, and -2. |
Active Comparator: Busulfan, Cyclophosphamide, and Fludarabine (Pediatric only)
On the day of your admission you will start to take a drug called Dilantin which is used to help prevent seizures while you receive your chemotherapy drugs.
You will also start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI.
On the next day, you will then begin your conditioning therapy with a drug called busulfan.
This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm four times per day for four days.
After the busulfan treatment, you will receive 4 doses each of two drugs, cyclophosphamide (also known as Cytoxan) and fludarabine, over 2 hours into your vein.
|
Will be given IV at 5 µg/kg/day. The first injection will be administered on day +7, i.e. 7 days after the hematopoietic stem cells are infused. Will be administered until the ANC is 1500 / µl for 2 days. Dose and schedule of G-CSF administration is left to each center's discretion.
Other Names:
For transplantation, the drug is diluted in 250 to 500 cc of NS or D5W and administered IV over 2 hours.
Initial doses will be administered IV at a starting dose of 1.5 mg/kg BID.
The infusion will vary from 2-24hr depending on the incidence of side-effects.
Administered on days +1, +3, and +7.
Mycophenolate may be used as a substitute for Methotrexate
A drug used to decrease the risk of graft versus host disease (GvHD).
Other Names:
The stem cells will be given to you by intravenous injection (through your vein) using a catheter that was placed prior to beginning chemotherapy.
The stem cell infusion takes 1-6 hours.
Patients who take the drug PO, busulfan will be administered at 1 mg/kg/ dose given by mouth every 6 hours for 16 consecutive doses.
Pediatric patients who receive busulfan IV continuous infusion will receive a dose of 3.0 mg/kg/IBW if under the age of 2.Pediatric patients over the age of 2 will receive busulfan at a dose of 0.8 mg/kg/dose.
Fludarabine administered at 30 mg/m2 IVPB infused over 30 minutes into right atrial catheter on days -4, -3, -2. Fludarabine administered at 40 mg/m2 IVPB infused over 30 into the right atrial catheter on days -5, -4, -3, and -2. |
Active Comparator: ATG For Cord Blood Transplants
If you are undergoing a pre-transplant conditioning regimen prior to undergoing a cord blood transplant, you will receive a drug called ATG to improve your chances of engraftment and decrease your risk of graft versus host disease.
You may receive ATG 3 times during your transplant regimen on days -3 through days -1 in addition to your pre-transplant conditioning therapy.
Methylprednisolone will also be given during each dose of ATG to help reduce any reactions during infusion.
|
Will be given IV at 5 µg/kg/day. The first injection will be administered on day +7, i.e. 7 days after the hematopoietic stem cells are infused. Will be administered until the ANC is 1500 / µl for 2 days. Dose and schedule of G-CSF administration is left to each center's discretion.
Other Names:
Initial doses will be administered IV at a starting dose of 1.5 mg/kg BID.
The infusion will vary from 2-24hr depending on the incidence of side-effects.
Administered on days +1, +3, and +7.
Mycophenolate may be used as a substitute for Methotrexate
A drug used to decrease the risk of graft versus host disease (GvHD).
Other Names:
The stem cells will be given to you by intravenous injection (through your vein) using a catheter that was placed prior to beginning chemotherapy.
The stem cell infusion takes 1-6 hours.
Intravenous, 1.5 mg/kg of body weight daily for 7 to 14 days The first dose should be administered over a minimum of 6 hours and over at least 4 hours on subsequent doses through a high-flow vein.
Other Names:
Methyl-prednisolone is administered IV as a rapid infusion.
The patient will receive ATG to improve the changes of engraftment and decrease their risk of graft versus host disease.
The patient may receive ATG 3 times during their transplant regimen on days -3 through days -1
|
Active Comparator: DLI (Donor Leukocyte Infusion)
Donor Leukocyte Infusions: You will receive DLI from your original transplant donor.
This will be given through a vein , usually in your arm.
It will be similar to getting a platelet or blood transfusion.
You may require more than one DLI.
The decision to give you another infusion will be determined by your condition, relapse status, GVHD and how much DLI you were given before.
You may need chemotherapy and/or radiation to improve your disease status prior to additional DLI's.
|
Will be given IV at 5 µg/kg/day. The first injection will be administered on day +7, i.e. 7 days after the hematopoietic stem cells are infused. Will be administered until the ANC is 1500 / µl for 2 days. Dose and schedule of G-CSF administration is left to each center's discretion.
Other Names:
Initial doses will be administered IV at a starting dose of 1.5 mg/kg BID.
The infusion will vary from 2-24hr depending on the incidence of side-effects.
Administered on days +1, +3, and +7.
Mycophenolate may be used as a substitute for Methotrexate
A drug used to decrease the risk of graft versus host disease (GvHD).
Other Names:
The stem cells will be given to you by intravenous injection (through your vein) using a catheter that was placed prior to beginning chemotherapy.
The stem cell infusion takes 1-6 hours.
|
Active Comparator: Cyclophosphamide, Etoposide (VP16) and TBI (Pediatric only)
On the day after your admission, you will start receiving radiation therapy (TBI).
Radiation will be given to you 2 times a day for 3 days.
On the next day, you will then begin your chemotherapy with a drug called etoposide.
This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm for one day.
After the etoposide treatment, on the next day you will receive cyclophosphamide (also known as Cytoxan) for 2 days.
When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage.
After you have completed the cyclophosphamide you will rest one day without any anti-cancer therapy.
This allows your body time to remove and inactivate the chemotherapy.
After a day of rest, you will be given your donor's cells.
|
Will be given IV at 5 µg/kg/day. The first injection will be administered on day +7, i.e. 7 days after the hematopoietic stem cells are infused. Will be administered until the ANC is 1500 / µl for 2 days. Dose and schedule of G-CSF administration is left to each center's discretion.
Other Names:
For transplantation, the drug is diluted in 250 to 500 cc of NS or D5W and administered IV over 2 hours.
Initial doses will be administered IV at a starting dose of 1.5 mg/kg BID.
The infusion will vary from 2-24hr depending on the incidence of side-effects.
Administered on days +1, +3, and +7.
Mycophenolate may be used as a substitute for Methotrexate
A drug used to decrease the risk of graft versus host disease (GvHD).
Other Names:
The stem cells will be given to you by intravenous injection (through your vein) using a catheter that was placed prior to beginning chemotherapy.
The stem cell infusion takes 1-6 hours.
Radiation will be given to you 2 times a day for 3 or 4 days.
Etoposide administration 200 mg /m2 dissolved in 1 liter NS and infused over 2 hours into right atrial catheter. Infusion to begin after cytarabine administration on days -5, -4, -3, -2. Etoposide administration 50 mg/kg IV over 24 hours, divided into 3 doses. Dilute in normal saline at a concentration of 0.4 mg/ml (Observe for precipitation). Administered IV with continuous infusion over 24 hours. Diuretics may be given for fluid overload. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Disease Free Survival (DFS).
Time Frame: Duration of the study; Up to 2 years
|
Determine the effectiveness of unrelated donor allogeneic hematopoietic stem cells for transplantation after conditioning for the treatment of high-risk hematopoietic malignancies. Disease-free survival: The length of time after treatment ends that a patient survives without any signs or symptoms of that cancer or any other type of cancer. |
Duration of the study; Up to 2 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Richard Maziarz, MD, OHSU Knight Cancer Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- primary myelofibrosis
- L3 childhood acute lymphoblastic leukemia
- L3 adult acute lymphoblastic leukemia
- stage III adult diffuse large cell lymphoma
- stage III adult immunoblastic large cell lymphoma
- stage III adult Burkitt lymphoma
- stage IV grade 3 follicular lymphoma
- stage IV adult diffuse large cell lymphoma
- stage IV adult immunoblastic large cell lymphoma
- stage IV adult Burkitt lymphoma
- recurrent grade 3 follicular lymphoma
- recurrent adult diffuse large cell lymphoma
- recurrent adult immunoblastic large cell lymphoma
- recurrent adult Burkitt lymphoma
- stage III childhood small noncleaved cell lymphoma
- stage IV childhood small noncleaved cell lymphoma
- stage IV childhood large cell lymphoma
- recurrent childhood small noncleaved cell lymphoma
- recurrent childhood large cell lymphoma
- refractory anemia
- refractory anemia with excess blasts
- refractory anemia with excess blasts in transformation
- chronic myelomonocytic leukemia
- de novo myelodysplastic syndromes
- previously treated myelodysplastic syndromes
- secondary myelodysplastic syndromes
- adult acute myeloid leukemia with 11q23 (MLL) abnormalities
- adult acute myeloid leukemia with t(15;17)(q22;q12)
- adult acute myeloid leukemia with t(16;16)(p13;q22)
- secondary acute myeloid leukemia
- childhood acute lymphoblastic leukemia in remission
- childhood acute myeloid leukemia in remission
- juvenile myelomonocytic leukemia
- chronic phase chronic myelogenous leukemia
- childhood chronic myelogenous leukemia
- childhood myelodysplastic syndromes
- recurrent adult acute myeloid leukemia
- adult acute myeloid leukemia in remission
- recurrent adult Hodgkin lymphoma
- recurrent/refractory childhood Hodgkin lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- recurrent adult diffuse mixed cell lymphoma
- blastic phase chronic myelogenous leukemia
- relapsing chronic myelogenous leukemia
- stage III grade 1 follicular lymphoma
- stage III grade 2 follicular lymphoma
- stage III grade 3 follicular lymphoma
- stage III adult diffuse small cleaved cell lymphoma
- stage III adult diffuse mixed cell lymphoma
- stage IV grade 1 follicular lymphoma
- stage IV grade 2 follicular lymphoma
- stage IV adult diffuse small cleaved cell lymphoma
- stage IV adult diffuse mixed cell lymphoma
- stage III mantle cell lymphoma
- stage IV mantle cell lymphoma
- stage II multiple myeloma
- stage III multiple myeloma
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- noncontiguous stage II grade 1 follicular lymphoma
- noncontiguous stage II grade 2 follicular lymphoma
- noncontiguous stage II adult diffuse small cleaved cell lymphoma
- noncontiguous stage II small lymphocytic lymphoma
- noncontiguous stage II marginal zone lymphoma
- recurrent marginal zone lymphoma
- recurrent small lymphocytic lymphoma
- stage III small lymphocytic lymphoma
- stage III marginal zone lymphoma
- stage IV small lymphocytic lymphoma
- stage IV marginal zone lymphoma
- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
- nodal marginal zone B-cell lymphoma
- splenic marginal zone lymphoma
- stage I multiple myeloma
- recurrent adult lymphoblastic lymphoma
- recurrent mantle cell lymphoma
- refractory chronic lymphocytic leukemia
- stage III chronic lymphocytic leukemia
- stage IV chronic lymphocytic leukemia
- stage III adult Hodgkin lymphoma
- stage IV adult Hodgkin lymphoma
- stage III adult lymphoblastic lymphoma
- stage IV adult lymphoblastic lymphoma
- refractory multiple myeloma
- recurrent adult acute lymphoblastic leukemia
- refractory hairy cell leukemia
- recurrent childhood acute lymphoblastic leukemia
- stage III childhood large cell lymphoma
- stage III childhood lymphoblastic lymphoma
- stage IV childhood lymphoblastic lymphoma
- noncontiguous stage II mantle cell lymphoma
- noncontiguous stage II adult diffuse large cell lymphoma
- noncontiguous stage II adult diffuse mixed cell lymphoma
- noncontiguous stage II adult lymphoblastic lymphoma
- noncontiguous stage II grade 3 follicular lymphoma
- accelerated phase chronic myelogenous leukemia
- adult acute lymphoblastic leukemia in remission
- L1 adult acute lymphoblastic leukemia
- L2 adult acute lymphoblastic leukemia
- L1 childhood acute lymphoblastic leukemia
- L2 childhood acute lymphoblastic leukemia
- stage IV childhood Hodgkin lymphoma
- recurrent childhood acute myeloid leukemia
- myelodysplastic/myeloproliferative neoplasm, unclassifiable
- chronic eosinophilic leukemia
- chronic neutrophilic leukemia
- atypical chronic myeloid leukemia, BCR-ABL negative
- noncontiguous stage II adult Burkitt lymphoma
- noncontiguous stage II adult immunoblastic large cell lymphoma
- recurrent childhood lymphoblastic lymphoma
- stage III childhood Hodgkin lymphoma
- unusual cancers of childhood
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Disease
- Bone Marrow Diseases
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Precancerous Conditions
- Neoplasms
- Lymphoma
- Syndrome
- Myelodysplastic Syndromes
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Leukemia
- Preleukemia
- Plasmacytoma
- Myeloproliferative Disorders
- Myelodysplastic-Myeloproliferative Diseases
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiviral Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Neuroprotective Agents
- Protective Agents
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Dermatologic Agents
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Antifungal Agents
- Reproductive Control Agents
- Antitubercular Agents
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Folic Acid Antagonists
- Antibiotics, Antitubercular
- Calcineurin Inhibitors
- Methylprednisolone
- Cyclophosphamide
- Etoposide
- Melphalan
- Fludarabine
- Fludarabine phosphate
- Cytarabine
- Methotrexate
- Tacrolimus
- Mycophenolic Acid
- Busulfan
- Carmustine
- Antilymphocyte Serum
- Cyclosporine
- Cyclosporins
Other Study ID Numbers
- CDR0000452794
- P30CA016058 (U.S. NIH Grant/Contract)
- OHSU-TPI-9695-L
- OHSU-540
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lymphoma
-
Marcela V. Maus, M.D.,Ph.D.RecruitingFollicular Lymphoma | Mantle Cell Lymphoma | Marginal Zone Lymphoma | Diffuse Large B Cell Lymphoma | Refractory Non-Hodgkin Lymphoma | Primary Mediastinal Large B-cell Lymphoma (PMBCL) | Non-hodgkin Lymphoma | High-grade B-cell Lymphoma | Grade 3b Follicular Lymphoma | Relapsed Non-Hodgkin LymphomaUnited States
-
Novartis PharmaceuticalsBristol-Myers SquibbRecruitingNon-Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone LymphomaUnited States, Germany, Italy, Korea, Republic of, Spain, Singapore, China, Japan, Australia
-
Zhejiang UniversityShanghai First Song Therapeutics Co., LtdNot yet recruitingHodgkin Lymphoma | Anaplastic Large Cell Lymphoma | Angioimmunoblastic T-cell Lymphoma | Diffuse Large B Cell Lymphoma | Gray Zone Lymphoma | NK/T Cell Lymphoma | Peripheral T Cell Lymphoma, Unspecified | Mediastinal B-Cell Diffuse Large Cell LymphomaChina
-
IGM Biosciences, Inc.ADC Therapeutics S.A.Active, not recruitingFollicular Lymphoma | Mantle Cell Lymphoma | Marginal Zone Lymphoma | Non-Hodgkin Lymphoma | DLBCLUnited States, Korea, Republic of, Spain, France, Australia, Czechia, Italy
-
Massachusetts General HospitalTG TherapeuticsActive, not recruitingLymphoma | Follicular Lymphoma | Marginal Zone Lymphoma | Follicular Lymphoma, Grade 1 | Follicular Lymphoma Grade IIIa | Marginal Zone B Cell Lymphoma | Follicular Lymphoma Grade 2United States
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedFollicular Lymphoma | Mantle Cell Lymphoma | Non-Hodgkin Lymphoma | B-Cell Non-Hodgkin Lymphoma | Adult Diffuse Large B-Cell Lymphoma | T-Cell Non-Hodgkin LymphomaUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedMantle Cell Lymphoma | Marginal Zone Lymphoma | Non-Hodgkin Lymphoma | Small Lymphocytic Lymphoma | Lymphoproliferative Disorder | Primary Cutaneous B-Cell Non-Hodgkin Lymphoma | Grade 1 Follicular Lymphoma | Grade 2 Follicular Lymphoma | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | Grade 3 Follicular... and other conditionsUnited States, Canada, Australia, Puerto Rico
-
Massachusetts General HospitalNational Comprehensive Cancer NetworkCompletedFollicular Lymphoma | Mantle Cell Lymphoma | Non-Hodgkin Lymphoma | Peripheral T-cell Lymphoma | Diffuse Large B-cell LymphomaUnited States
-
Novartis PharmaceuticalsCompletedDiffuse Large B-cell Lymphoma, Mantle Cell Lymphoma, Follicular LymphomaUnited States, Belgium, Germany, France, Italy, Korea, Republic of, Spain, Turkey
-
Ruijin HospitalThe First Affiliated Hospital with Nanjing Medical University; Shanxi Province... and other collaboratorsNot yet recruitingLymphoma | Marginal Zone Lymphoma | Anaplastic Large Cell Lymphoma | Angioimmunoblastic T-cell Lymphoma | Diffuse Large B Cell Lymphoma | Mucosa-Associated Lymphoid Tissue Lymphoma | Intravascular Large B-Cell Lymphoma | Extranodal Lymphoma | NK/T-Cell Lymphoma, Nasal and Nasal-TypeChina
Clinical Trials on filgrastim
-
Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedNon-Hodgkin's Lymphoma | Plasma Cell MyelomaUnited States
-
Franziska WachterHarvard Clinical and Translational Science Center (Harvard Catalyst)RecruitingAcute Myeloid Leukemia | Myelodysplastic Syndromes | MDS | Aml | Myeloid Neoplasm | Myeloid Malignancies | Inherited Bone Marrow Failure SyndromeUnited States
-
National Cancer Institute (NCI)CompletedRhabdomyosarcoma | Synovial Sarcoma | Ewing's Sarcoma | MPNST | High-risk SarcomaUnited States
-
Trio FertilityRecruitingPrimary Ovarian Insufficiency | Premature Ovarian FailureCanada
-
Ottawa Hospital Research InstituteCompletedEarly Stage Breast CancerCanada
-
Eurofarma Laboratorios S.A.CompletedNeutropenia in Breast CancerBrazil
-
Medical University of BialystokUnknownIncrease Muscle Strength in Patients With Muscular DystrophyPoland
-
PfizerCompletedHealthy VolunteersUnited States
-
Seoul St. Mary's HospitalUnknownLeukemia, Myeloid, AcuteKorea, Republic of
-
Andrews Research & Education FoundationFloridaRecruiting