Clinical trial · Interventional
S0501 Fludarabine, Melphalan, and Donor Stem Cell Transplant Followed By Tacrolimus and Methotrexate in Treating Patients for Relapsed Lymphoma
Nonmyeloablative Allogeneic Stem Cell Transplantation For Relapsed Hodgkin's or Non-Hodgkin's Lymphoma After Autologous Transplantation ( A BMT Study)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): poor accrual
Summary
Brief summary (as posted)
RATIONALE: Giving low doses of chemotherapy, such as fludarabine and melphalan, before a donor bone marrow or peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus and methotrexate after transplant may stop this from happening. PURPOSE: This phase II trial is studying how well giving fludarabine together with melphalan followed by tacrolimus and methotrexate works in treating patients who are undergoing a donor stem cell transplant for relapsed lymphoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| allogeneic bone marrow transplantation | Procedure | — | UNRESOLVED |
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
| melphalan | Drug | Melphalan | ALIAS |
| methotrexate | Drug | Methotrexate | ALIAS |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| tacrolimus | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Nonmyeloablative allogeneic stem cell transplant
- description
- Patients are given fludarabine 30 mg/m\^2 on days -6 to -2 and melphalan 70 mg/m\^2 on days -3 and -2, then transplanted with donor peripheral blood stem cells or harvested bone marrow stem cells on day 0. Patients are then given post-transplant immunosuppression consisting of tacrolimus 0.06 mg/kg/day on days -3 to 100 and methotrexate 5 mg/m\^2 on days 1, 3, and 7.
- interventionNames
- Drug: fludarabine phosphate
- Drug: melphalan
- Drug: methotrexate
- Drug: tacrolimus
- Procedure: allogeneic bone marrow transplantation
- Procedure: peripheral blood stem cell transplantation
Primary outcomes (2)
- measure
- Progression-free Survival
- timeFrame
- 1, 3, and 12 months after protocol treatment, then every 3 months for 1 year, every 6 months for year 2, then annually thereafter until 5 years after registration
- description
- PFS rate at 1 year.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of lymphoma of 1 of the following types:
* Diffuse large B-cell lymphoma
* Follicular lymphoma
* Grades 1, 2, or 3
* Primary mediastinal lymphoma
* Mantle cell lymphoma
* Small lymphocytic lymphoma
* Hodgkin's lymphoma
* Transformed lymphoma
* Relapsed after prior autologous bone marrow transplantation (BMT)
* More than 180 days post BMT
* Received ≥ 1 course of chemotherapy after BMT relapse
* Achieved a complete response OR a partial response to chemotherapy
* Largest residual tumor dimension ≤ 2 cm
* No clinical or laboratory evidence of CNS involvement by lymphoma
* HLA-identical donor available, meeting 1 of the following criteria:
* Sibling donor with 5/6 or 6/6 alleles matching by genotyping
* No monozygotic identical twins
* Unrelated donor with 10/10 alleles matching by genotyping
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Zubrod 0-2
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
Cardiovascular
* LVEF ≥ 40% by MUGA or 2-D echocardiogram (2-D ECHO)
* No significant cardiac abnormalities by MUGA or 2-D ECHO
* No uncompensated coronary artery disease by ECG or physical exam
* None of the following within the past 6 months:
* Myocardial infarction
* Unstable angina
* Uncontrolled atrial fibrillation
* None of the following within the past 3 months:
* Severe peripheral vascular disease
* Venous stasis ulcers
* Deep venous or arterial thrombosis
* No uncontrolled hypertension
Pulmonary
* DLCO (corrected) and total lung capacity ≥ 40% of predicted
* No requirement for continuous supplemental oxygen
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV negative
* No AIDS
* No active bacterial, viral, or fungal infection
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* No history of uncontrolled seizures
* No diabetic ulcers within the past 3 months
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Disease Characteristics
* No more than 1 prior bone marrow transplantation
Chemotherapy
* See Disease Characteristics
* More than 21 days since prior chemotherapy and recovered
Endocrine therapy
* Not specified
Radiotherapy
* More than 4 weeks since prior radiotherapy
Surgery
* More than 4 weeks since prior major surgery except placement of a venous access deviceReferences
Publications (0)
Data not yet available