Clinical trial · Interventional
Imatinib Mesylate, Busulfan, Fludarabine, and Antithymocyte Globulin for CML Patients
Imatinib Mesylate, Busulfan, Fludarabine, Antithymocyte Globulin and Allogeneic Stem Cell Transplantation for Chronic Myelogenous Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Support issue.
Summary
Brief summary (as posted)
Primary Objective: To estimate the probability of molecular complete remission at one year for the described sequential treatment approach, with nonablative hematopoietic transplantation, post transplant imatinib mesylate and donor lymphocyte infusion, in patients with Ph-positive Chronic Myelogenous Leukemia (CML) not in blastic transformation. Secondary Objective: Response to post transplant Imatinib mesylate therapy for 12 weeks as treatment of residual disease, response to donor lymphocyte infusion (DLI) for residual disease following imatinib mesylate therapy, as well as engraftment, toxicity, disease free survival and survival, effect of busulfan pharmacokinetics on study outcome.
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 |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Antithymocyte Globulin (ATG) | Drug | — | UNRESOLVED |
| Busulfan | Drug | Busulfan | ALIAS |
| Donor lymphocyte infusion (DLI) | Procedure | — | UNRESOLVED |
| Fludarabine (Fludara) | Drug | Fludarabine | ALIAS |
| Imatinib Mesylate | Drug | Imatinib Mesylate | ALIAS |
| Methotrexate | Drug | Methotrexate | ALIAS |
| Stem Cell Transplant | Procedure | — | UNRESOLVED |
| Tacrolimus | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Imatinib, Busulfan, Fludara + Antithymocyte Globulin
- description
- Oral Imatinib Mesylate 400 mg twice a day for 9 Days; Busulfan 130 mg/m\^2 by vein (IV) daily for 2 Days; Fludara 40 mg/m\^2 IV daily for 4 Days; Antithymocyte Globulin (ATG) 2.5 mg/kg IV daily for 3 Days; Tacrolimus levels maintained between 5-15 ng/dl, Day -2 to Day 180; Methotrexate 5 mg/m2 on days 1, 3, 6 and 11; and Donor bone marrow or blood stem cells infused on day 0 with possible donor lymphocyte infusion (DLI) for progressive disease.
- interventionNames
- Drug: Imatinib Mesylate
- Drug: Fludarabine (Fludara)
- Drug: Busulfan
- Drug: Antithymocyte Globulin (ATG)
- Drug: Tacrolimus
- Drug: Methotrexate
- Procedure: Donor lymphocyte infusion (DLI)
- Procedure: Stem Cell Transplant
Primary outcomes (1)
- measure
- Number of Participants in Complete Molecular Remission at 1 Year
- timeFrame
- Baseline to 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Diagnosis of Ph+ chronic myelogenous leukemia (CML) in first chronic phase without a complete hematologic response after 3 months of Imatinib mesylate therapy, or \>=35% Ph+ cells despite \> 6 months of Imatinib mesylate treatment, or after disease progression from a complete or partial response. Any patient with accelerated phase or blast crisis who achieves a subsequent chronic phase is eligible. Patients must have an HLA matched related or unrelated donor or one antigen mismatched related donor. 2. Patients should be less than 70 years of age. Patients less than 30 years of age who achieve a hematologic remission with imatinib therapy are eligible regardless of cytogenetic response. 3. Patients are stratified as Group 1: First chronic phase, Group 2 Accelerated phase or blast crisis that achieved a hematologic remission with imatinib mesylate-based treatment. Exclusion Criteria: 1. Zubrod Performance Scale (PS) \>=2, uncontrolled infection, Creatinine \> 2.0 mg/dl; Ejection fraction \< 40%; Carbon Monoxide Diffusing Capacity (DLCO) \< 45% of predicted; Serum bilirubin \> 2 gm/dl; GPT (Glutamic-pyruvic transaminase) or GOT (glutamic-oxaloacetic transaminase)\> 3 times normal values. Patients should not be human immunodeficiency virus (HIV) seropositive or pregnant. 2. Patients should not have progressed to accelerated phase or blast crisis while receiving imatinib mesylate containing therapy.
References
Publications (0)
Data not yet available