Clinical trial · Interventional
Cyclophosphamide and/or Mycophenolate Mofetil With or Without Tacrolimus in Treating Patients Who Are Undergoing a Donor Bone Marrow or Peripheral Stem Cell Transplant for Hematologic Cancer
Nonmyeloablative Bone Marrow Transplants in Hematologic Malignancies: Dose Finding Study for Post-Transplant Immunosuppression
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Giving low doses of chemotherapy, such as fludarabine, and radiation therapy before a donor bone marrow or 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 cyclophosphamide, mycophenolate mofetil, and tacrolimus after transplant may stop this from happening. PURPOSE: This phase I trial is studying cyclophosphamide and/or mycophenolate mofetil with or without tacrolimus to see which is the best regimen in treating patients who are undergoing a donor bone marrow or stem cell transplant for hematologic cancer.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myeloproliferative Disorders | Myeloproliferative Neoplasm | ALIAS | 0.90 |
| Graft Versus Host Disease | — | UNRESOLVED | — |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Multiple Myeloma and Plasma Cell Neoplasm | — | UNRESOLVED | — |
| Myelodysplastic/Myeloproliferative Diseases | Myelodysplastic/Myeloproliferative Neoplasm | ALIAS | 0.90 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| allogeneic bone marrow transplantation | Procedure | — | UNRESOLVED |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
| mycophenolate mofetil | Drug | — | UNRESOLVED |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
| tacrolimus | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Post-transplant immunosuppression regimen with ≤ 20% incidence of a grade II-IV graft-versus-host-disease (GVHD) and < 10% incidence of nonengraftment (< 5% donor chimerism) at day 60 following transplant
- measure
- Incidence and severity of acute GVHD at day 60 following transplant
- measure
- Frequency of mixed chimerism defined as any detectable donor cells at day 60 following transplant
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of 1 of the following hematologic malignancies:
* Stage II or III multiple myeloma
* Amyloidosis
* Myelofibrosis with ≥ 2 of the following high-risk features:
* Over 55 years of age
* Hemoglobin \< 10 g/dL
* WBC \< 3,000/mm\^3 OR \> 10,000/mm\^3
* Platelet count \< 100,000/mm\^3
* Cytogenetic abnormalities
* Mycosis fungoides, meeting 1 of the following criteria:
* Stage IIB or III disease with evidence of histologic conversion to an aggressive lymphoma
* Must demonstrate chemosensitivity
* Stage IV disease
* Paroxysmal nocturnal hemoglobinuria
* Not meeting criteria for other bone marrow transplantation (BMT) or treatment studies
* Diagnosis of 1 of the following hematologic malignancies, for which patient is not eligible for potentially curative allogeneic BMT due to end-organ dysfunction, age 65 to 75, or the amount of prior chemotherapy:
* Acute myeloid or acute lymphoblastic leukemia
* High-risk disease in first or second (or further) complete remission
* Relapsed aggressive non-Hodgkin's lymphoma
* Not eligible for autologous or standard allogeneic BMT
* Hodgkin's lymphoma in second or further complete or partial remission
* Not eligible for autologous or standard allogeneic BMT
* Myelodysplastic syndromes or myelodysplastic/myeloproliferative diseases
* Any of the following subtypes:
* Refractory anemia with excess blasts (RAEB)
* RAEB in transformation
* Chronic myelomonocytic leukemia
* Any morphologic subtype with multiple chromosomal abnormalities
* Any subset with life-threatening cytopenias in all 3 cell lines, defined as platelet count ≤ 20,000/mm\^3, absolute neutrophil count ≤ 500/mm\^3, and reticulocyte count ≤ 50,000/mm\^3
* Meets both of the following criteria:
* Less than 20% blasts by bone marrow biopsy
* Not eligible for standard allogeneic BMT
* No refractory anemia with ringed sideroblasts
* No 5q syndrome
* Stage III or IV chronic lymphocytic leukemia
* Not meeting criteria for other BMT studies
* Chronic myelogenous leukemia in first or second chronic phase
* Not meeting criteria for other BMT studies or treatment
* Stage III or IV indolent small lymphocytic or follicular lymphoma
* Not eligible for autologous or standard allogeneic BMT or other active protocols at Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
* Must have an HLA-identical related donor available
PATIENT CHARACTERISTICS:
Performance status
* ECOG 0-2
Life expectancy
* Not specified
Hematopoietic
* See Disease Characteristics
Hepatic
* Bilirubin ≤ 3.0 mg/dL
* AST ≤ 175 U/L
* ALT ≤ 200 U/L
Renal
* Creatinine ≤ 3.0 mg/dL
Cardiovascular
* LVEF ≥ 30%
Pulmonary
* FEV\_1 ≥ 40% predicted
* Forced vital capacity ≥ 40% predicted
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV negative
PRIOR CONCURRENT THERAPY:
Chemotherapy
* See Disease CharacteristicsReferences
Publications (0)
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