- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00167180
Post Transplant Donor Lymphocyte Infusion
Use of Cyclophosphamide/Fludarabine to Promote in Vivo Expansion of Donor Lymphocyte Infusions (DLI) to Enhance Efficacy After Allogeneic Transplant
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Minnesota
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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 (age > or = 1 years) with a diagnosis of relapse after related or unrelated allogeneic stem cell transplantation for a hematological malignancy.
- For CML, relapse will be defined as any cytogenetic evidence of a Philadelphia chromosome or persistence of BCR/ABL rearrangements by molecular testing on at least two measurements over a 6 month interval. If cytogenetics are normal and there is PCR evidence of a BCR/ABL fusion, patients will be eligible if they have evidence of a quantitative increase in CML measured either by quantitative PCR or by fluorescent in situ hybridization (FISH).
- For non-CML, relapse will be defined based on disease specific morphologic criteria from a bone marrow biopsy and aspirate or recurrence of disease specific cytogenetics. For disease specific definition of relapse, see appendix 3. Relapse can be determined morphologically with less than 5 percent blasts if definitive relapse can be determined. Equivocal results for relapse should result in a repeated test after an appropriate time interval (suggested 1 month) to determine eligibility.
Post-transplant lymphoproliferative diseases (often referred to as EBV-associated lymphomas) are NOT eligible for this protocol.
- For Chronic Phase CML patients only
- - must have failed (no response in 3 months or incomplete response at 6 months) or refused treatment with Gleevec
- - if no prior DLI, CML patients will first have DLI- if relapse occurs after DLI, DLI with chemotherapy per this protocol will be offered
- Patients must be within one year of identification of relapse or if beyond that time period, must have at least 10% donor DNA by RFLP or cytogenetics.
- Same allogeneic donor (sibling or URD) used for transplantation is available for lymphocyte donation.
- No severe organ damage (by laboratory or clinical assessment) as measured by:
- - blood creatinine ≤ 2.0 mg/dL
- - liver function tests < 5 x normal
- - left ventricular ejection fraction > 40% (testing required only if symptomatic or prior known impairment).
- - pulmonary functions > 50% (testing required only if symptomatic or prior known impairment). Oxygen saturation (>92%) can be used in child where PFT's cannot be obtained.
- - chest x-ray without evidence of active infection
- Off prednisone and other immunosuppressive agents (given for any reason) for at least 3 days prior to DLI infusions.
- Performance status ≥ 60%
- Women must not be pregnant or lactating. The agents used in this study may be teratogenic to a fetus and there is no information on the excretion of agents into breast milk All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy
- Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception
- Patient must given written informed consent indicating understanding of the nature of the treatment and its potential risks
Exclusion Criteria:
- Concurrent signs of acute or chronic graft-versus-host disease requiring ongoing treatment at the time of relapse will be ineligible.
- Patients being treated for GVHD with prednisone, cyclosporine, Imuran or other immunosuppressive medications are not eligible until these medications are discontinued for at least 2 weeks without a flare of GVHD.
- Active CNS leukemia
- Active fungal infection or pulmonary infiltrates (stable prior treated disease is allowable)
- HIV positive
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: CML
Patients with Chronic Myelogenous Leukemia (CML) who have failed or refused Gleevec(TM) therapy and will receive Donor Lymphocyte Infusion.
|
donor cells infused over 2 hrs at cell dose of 0.5 dx 10^8 CD3+T-cells/kg
Other Names:
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Active Comparator: Non-CML or CML that Relapsed after Donor Lymphocyte Infusion
Patients with non-CML or CML who have failed Donor Lymphocyte Infusion (DLI) and will receive induction chemotherapy plus DLI.
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donor cells infused over 2 hrs at cell dose of 0.5 dx 10^8 CD3+T-cells/kg
Other Names:
Fludarabine 25 mg/m2 IV Cyclosphosphamide 60 mg/kg IV
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Patients Alive
Time Frame: 1 Year
|
The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate. Overall survival will be defined as time from date of enrollment to date of death or censored at the date of last documented contact for patients still alive. |
1 Year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Patients Alive Without Disease
Time Frame: 1 Year
|
The number of patients alive one year after treatment without any signs or symptoms of the cancer being treated or any other type of cancer.
In a clinical trial, measuring the disease-free survival is one way to see how well a new treatment works.
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1 Year
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Number of Participants With Complete Remission
Time Frame: one year
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In complete remission, all signs and symptoms of cancer that can be detected with modern technology have disappeared, although cancer still may be in the body.
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one year
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Number of Patients With Acute Graft-Versus-Host Disease
Time Frame: Day 100
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Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host.
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Day 100
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Number of Patients With Bone Marrow Aplasia
Time Frame: Day 100
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Aplastic anemia is a disorder in which the bone marrow greatly decreases or stops production of blood cells. In aplastic anemia, the basic structure of the marrow becomes abnormal, and those cells responsible for generating blood cells (hematopoietic cells) are greatly decreased in number or absent. These hematopoietic cells are replaced by large quantities of fat. |
Day 100
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jeffrey Miller, MD, Masonic Cancer Center, University of Minnesota
Publications and helpful links
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
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Bone Marrow Diseases
- Hematologic Diseases
- Hemorrhagic Disorders
- Myeloproliferative Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Neoplasms, Plasma Cell
- Leukemia, B-Cell
- Myelodysplastic Syndromes
- Multiple Myeloma
- Leukemia
- Leukemia, Myeloid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Cyclophosphamide
Other Study ID Numbers
- 2004LS006
- MT2003-15 (Other Identifier: Blood and Marrow Transplantation Program)
- 0401M55207 (Other Identifier: IRB, University of Minnesota)
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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