Clinical trial · Interventional
Cyclophosphamide Plus Bone Marrow Transplantation in Treating Patients With Hematologic Cancer
Non-Myeloablative Allogeneic Bone Marrow Transplantation for Hematologic Malignancies Using Haploidentical Donors: A Phase I Trial of Pre-Transplant Cyclophosphamide
NCT00006042CI-TRIAL-00003254completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill cancer cells. PURPOSE: Phase I trial to study the effectiveness of cyclophosphamide plus bone marrow transplantation in treating patients who have hematologic cancer.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| 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 (7)
| 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 |
| radiation therapy | Radiation | — | UNRESOLVED |
| tacrolimus | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 70 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Patients with any of the following diagnoses:
* Chronic myelogenous leukemia
* Chronic phase 1
* Failed prior interferon alfa therapy OR
* Relapsed after prior autologous stem cell transplantation
* Chronic phase 2
* Acute leukemia
* Standard risk
* Age over 60 years
* Complete remission 1 (CR1)
* High risk
* High WBC at presentation, unfavorable cytogenetics, mixed lineage, delayed response to induction chemotherapy
* CR1
* Complete remission 2 or higher
* Acute lymphocytic leukemia
* CR1 or higher
* Myelodysplastic syndrome
* Untreated OR
* CR1
* Acute myeloid leukemia in CR1
* Chronic lymphocytic leukemia
* Rai stage III or IV OR
* Received prior autologous stem cell transplantation
* Multiple myeloma
* Stage II or III
* Stable or progressive disease after prior chemotherapy OR
* Received prior autologous stem cell transplantation
* Non-Hodgkin's Lymphoma
* Hodgkin's lymphoma
* Ineligible for or refused autologous or standard allogeneic bone marrow transplantation
* Ineligible for bone marrow transplantation from an HLA matched, sibling donor or from an HLA matched, unrelated donor
* Must have an HLA mismatched, related donor (3-5 out of 6)
PATIENT CHARACTERISTICS:
Age:
* 0.5 to 70
Performance status:
* ECOG 0-1
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Bilirubin less than 3.1 mg/dL
Renal:
* Not specified
Cardiovascular:
* Left ventricular ejection fraction at least 35%
Pulmonary:
* FEV\_1 and FVC at least 40% of predicted OR
* FEV\_1 and FVC at least 60% in patients who have received prior thoracic or mantle radiotherapy
Other:
* HIV negative
* No other debilitating medical or psychiatric illness that would preclude study compliance
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* See Disease Characteristics
* No prior transfusions from donor
Chemotherapy:
* See Disease Characteristics
Endocrine therapy:
* Not specified
Radiotherapy:
* Not specified
Surgery:
* Not specifiedReferences
Publications (1)
- RESULTO'Donnell PV, Luznik L, Jones RJ, Vogelsang GB, Leffell MS, Phelps M, Rhubart P, Cowan K, Piantados S, Fuchs EJ. Nonmyeloablative bone marrow transplantation from partially HLA-mismatched related donors using posttransplantation cyclophosphamide. Biol Blood Marrow Transplant. 2002;8(7):377-86. doi: 10.1053/bbmt.2002.v8.pm12171484. PMID 12171484