- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00176839
Stem Cell Transplantation for Hematological Malignancies
Busulfan, Cyclophosphamide, and Melphalan Followed by Allogeneic Hematopoietic Cell Transplantation in Patients With Hematological Malignancies
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Subjects will be admitted to the bone marrow transplant unit and put in isolation to reduce exposure to infectious agents.
Prior to transplantation, they will receive BUSULFAN via the central venous line, four times a day for four days, CYCLOPHOSPHAMIDE via the central venous line once a day for two days, and MELPHALAN via the central venous line for one day. Busulfan, cyclophosphamide, and melphalan are given to destroy the subject's cancer. As well, these drugs will destroy their immune system to help ensure the new stem cells take and grow after transplantation.
On the day of transplantation, umbilical cord blood from the donor will be transfused via venous line. These new cells will replace the subject's bone marrow.
After transplantation, the subjects will receive Cyclosporin A and either MMF or MTX
Isolation will be continued until adequate numbers of cells are present in the blood to fight infection. Subjects will be discharged from the hospital when medically ready. They will be expected to return for follow-up to the blood and marrow transplant clinic at specific dates as determined by physicians.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55455
- Masonic Cancer Center, University of Minnesota
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients must have a diagnosis of acute lymphocytic leukemia (ALL), acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) and currently be in complete remission.
- Patients must be either:
- - <18 years of age who are at least 6 months after initial hematopoietic cell transplant (HCT),
- - 19-35 years of age and at least 18 months after initial HCT, or
- - <35 years of age and have received sufficient radiation treatment to be ineligible for total body irradiation (TBI) containing preparative therapy
- Adequate major organ function including:
- - Cardiac: ejection fraction > or = 45%
- - Renal: creatinine clearance > or = 40 mL/min
- - Hepatic: no clinical evidence of hepatic failure (e.g. coagulopathy, ascites)
- - Karnofsky performance status > or = 70% or Lansky score > or = 50%
- Women of child bearing age must be using adequate birth control and have a negative pregnancy test.
- Written informed consent.
Exclusion Criteria:
- Eligible for TBI containing preparative regimen.
- Active uncontrolled infection within one week of HCT.
- Pregnant or lactating females.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment Arm
Patients treated with therapy plan consisting of Busulfan every 6 hours on days -7 through -4, Cyclophosphamide 60 mg/kg/day IV x 2 days, Melphalan 140 mg/m on day -1, antithymocyte globulin (ATG), G-CSF (granulocyte colony-stimulating factor) and stem cell transplantation on day 0.
|
Certain cancers can be treated by giving patients stem cells that come from someone else.
This is called a stem-cell transplant.
As part of the transplant process, patients receive high doses of chemotherapy and/or radiation to treat their underlying disease, such as cancer.
As one of its effects, this treatment also kills the healthy stem cells that are already in the marrow.
The transplant provides new stem cells for the patient from a healthy donor; that replace the bone marrow and allow the blood counts to recover.
Other Names:
Prior to transplantation, subjects will receive BUSULFAN via the central venous line, four times a day for four days (days -7 through -4).
Other Names:
Prior to stem cell transplantation, subjects will receive CYCLOPHOSPHAMIDE via the central venous line once a day for two days on days -3 and -2.
Other Names:
MELPHALAN will be given via the central venous line for one day, on day -1, prior to stem cell transplantation.
Other Names:
G-CSF is to be given daily IV beginning on day +1 until ANC 2.5 x 109/L.
Other Names:
ATG will be administered to umbilical cord blood recipients.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Probability of Long-term Disease-free Survival (DFS)
Time Frame: 1 year
|
Number of participants with long-term disease free survival after being treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Probability of Engraftment
Time Frame: 1 year
|
Number of participants with engraftment after being treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies..
|
1 year
|
Incidence of Acute Graft-versus-host Disease (GVHD)
Time Frame: 100 days post-transplant
|
Number of participants with acute GVHD after being treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies.
|
100 days post-transplant
|
Incidence Chronic Graft-versus-host Disease (GVHD)
Time Frame: 1 year
|
Number of participants with chronic GVHD after being treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies.
|
1 year
|
Incidence of Regimen-related Toxicity 100 Days Post Transplant
Time Frame: 100 days post-transplant
|
Number of participants with regimen-related toxicity 100 days post transplant after being treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies.
|
100 days post-transplant
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Incidence of Relapse
Time Frame: 1 year
|
Number of patients with relapse after being treated with busulfan (BU), cyclophosphamide (CY) and melphalan (L-PAM) followed by HCT for hematological malignancies.
|
1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Margaret MacMillan, MD, Masonic Cancer Center, University of Minnesota
Study record dates
Study Major Dates
Study Start (Actual)
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
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Neoplasms by Site
- Hematologic Diseases
- Leukemia
- Neoplasms
- Hematologic Neoplasms
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Leukemia, Lymphoid
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Adjuvants, Immunologic
- Cyclophosphamide
- Lenograstim
- Melphalan
- Busulfan
- Antilymphocyte Serum
Other Study ID Numbers
- 2000LS040
- MT2000-12 (Other Identifier: Blood and Marrow Transplantation Program)
- 0005M52481 (Other Identifier: Institutional Review Board, University of Minnesota)
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.
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