Clinical trial · Interventional
Chemotherapy Followed by Allogeneic Stem Cell Transplantation for Hematologic Malignancies
Non-Myeloablative Chemotherapy Followed by HLA-Matched Related Allogeneic Stem Cell Transplantation for Hematologic Malignancies
NCT00741455CI-TRIAL-00048440completedN/AResults postedClinicalTrials.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)
The purpose of this study is to determine disease-free survival, overall survival, time to progression, regimen-related toxicity and/or treatment-related mortality in patients with hematologic malignancies treated with non-myeloablative chemotherapy followed by allogeneic stem cell transplant.
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 |
|---|---|---|---|
| Hematologic Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Cyclosporine | Drug | — | UNRESOLVED |
| Fludarabine | Drug | Fludarabine | ALIAS |
| G-CSF | Drug | — | UNRESOLVED |
| Methotrexate | Drug | Methotrexate | ALIAS |
| Stem Cell Transplant | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Study Treatment
- description
- Chemotherapy, stem cell transplantation, HLA-Matched related allogeneic stem cell transplantation, leukapheresis, G-CSF, peripheral blood stem cell transplant, fludarabine, cyclophosphamide, donor lymphocyte infusion, cyclosporine, methotrexate
- interventionNames
- Procedure: Stem Cell Transplant
- Drug: G-CSF
- Drug: Fludarabine
- Drug: cyclophosphamide
- Drug: Cyclosporine
- Drug: Methotrexate
Primary outcomes (1)
- measure
- Number of Participants With Successful Bone Marrow Engraftment
- timeFrame
- Within 30 days of bone marrow transplant
- description
- Rates of successful engraftment.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria:
* Age: 18-75 years
* Diseases
1. Chronic myelogenous leukemia (CML)
* First chronic phase or later
* Accelerated phase
2. Acute myelogenous or lymphoblastic leukemia (AML or ALL)
* Second or subsequent remission
* Patients who have failed an autologous PBSC transplant
* First remission with poor risk features, including, but not limited to: For AML- complex chromosome karyotype, abnormalities of chromosome 5 or 7, 12p-, 13+, 8+, t(9;22), t(11;23) For ALL- t(9;22), t(4;11), t(1;19), myeloid antigen coexpression
3. Myelodysplastic syndrome (MDS)
4. Multiple myeloma - high risk myeloma (poor responders, relapse after autologous PBSCT, chromosome 13 abnormalities)
5. Hodgkin's disease
* Primary refractory disease
* Relapsed disease (first relapse or later)
* Patients who have failed an autologous PBSC transplant
6. Non-Hodgkin's lymphoma Low grade (by Working Formulation)
* Relapsed, progressive disease after initial chemotherapy
* Primary refractory disease or failure to respond (\>PR) to initial chemotherapy
* Patients who have failed an autologous PBSC transplant Intermediate grade (by Working Formulation)
* Relapsed disease
* Primary refractory disease or failure to respond (\>PR) to initial chemo
* Mantle cell lymphoma
* Patients who have failed an autologous PBSC transplant
7. Chronic lymphocytic leukemia (CLL)
* Patients newly diagnosed with poor prognostic factors, including CD38 expression, Chromosome 11 or 17 abn
* T-CLL/PLL
* Relapsed or progressive disease, or refractory after Fludarabine
* Patients who have failed an autologous PBSC transplant
* Donor Availability: Six of six matched HLA A, B and DR identical sibling (or parent or child) or 5/6 related donor with single mismatch at Class I antigen (A or B)
* Karnofsky performance status of \>70%
* Serum bilirubin \<2x upper limit of normal; transaminases \<3x normal (unless due to disease)
* 24 hr urine creatinine clearance of \>40 ml/min.
* DLCO \>50% predicted
* Left ventricular ejection fraction \>35%
* No active infection
* Non-pregnant female
* Signed informed consent
* No major organ dysfunction or psychological problems that preclude compliance and completion of the clinical trial.
Exclusion Criteria
* Major organ dysfunction
* Pregnant or lactating female
* Active infection
* Psychological problems that preclude compliance and completion of the clinical trial
* Any other condition, that in the judgement of the investigator, affects participant safety or overall participationReferences
Publications (0)
Data not yet available
No reference posted for this study.