Clinical trial · Interventional
Fludarabine and Radiation Therapy in Treating Patients Who Are Undergoing Donor Stem Cell Transplant for Chronic Phase or Accelerated Phase Chronic Myelogenous Leukemia
A Multi-Center Phase II Study of Nonmyeloablative Conditioning With TBI and Fludarabine for HLA-Matched Related Hematopoietic Cell Transplantation for Treatment of Chronic Myeloid Leukemia in Chronic and Accelerated Phase
- 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 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). Giving an infusion of the donor's T cells (donor lymphocyte infusion) or interferon alfa after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from happening. PURPOSE: This phase II trial is studying how well giving fludarabine together with radiation therapy works in treating patients who are undergoing donor stem cell transplant for chronic phase or accelerated phase chronic myelogenous leukemia.
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 |
|---|---|---|---|
| cyclosporine | Drug | — | UNRESOLVED |
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
| imatinib mesylate | Drug | Imatinib Mesylate | ALIAS |
| mycophenolate mofetil | Drug | — | UNRESOLVED |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
| recombinant interferon alfa | Biological | — | UNRESOLVED |
| therapeutic allogeneic lymphocytes | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Progression-free survival
Secondary outcomes (6)
- measure
- Rate of complete molecular response
- measure
- Late nonrelapse mortality
- measure
- Incidence and severity of graft-vs-host disease (GVHD)
- measure
- Incidence of serious infections
- measure
- Myelosuppression
- measure
- Overall survival and disease-free survival
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia, meeting 1 of the following criteria:
* Chronic phase
* Ph+ by cytogenetics or fluorescent in situ hybridization (FISH) assay
* Accelerated phase, meeting any of the following criteria:
* More than 10% but \< 30% myeloblasts and promyelocytes in marrow or peripheral blood
* Any additional clonal cytogenetic abnormalities
* Increasing splenomegaly
* Extramedullary tumor
* WBC, platelet count, or hematocrit perturbations not controlled by therapy with hydroxyurea, interferon, or imatinib mesylate
* Persistent unexplained fever or bone pain
* Less than 5% blasts in the marrow at time of transplantation
* Not eligible for OR refused conventional myeloablative allogeneic stem cell transplantation
* Failed OR suboptimal response to prior imatinib mesylate, as defined by 1 of the following:
* Absence of complete hematologic response after \> 3 months of treatment with imatinib mesylate
* Absence of cytogenetic response, as defined by 1 of the following:
* Absence of any cytogenetic response (\< 95% Ph+ or BCR/ABL+ cells by cytogenetic or FISH analysis, respectively) after 6 months of treatment with imatinib mesylate
* Absence of major cytogenetic response (\< 35% Ph+ or BCR/ABL+ cells by cytogenetic or FISH analysis, respectively) after 1 year of treatment with imatinib mesylate
* Absence of complete cytogenetic response (no Ph+ cells by cytogenetic analysis OR BCR/ABL+ cells within normal limits by FISH analysis) after 18 months of treatment with imatinib mesylate
* Hematologic evidence of disease progression
* Cytogenetic evidence of disease progression
* Increase in Ph+ cells or BCR/ABL+ cells by \> 20% with at least 1 month between sequential testing
* Molecular evidence of disease progression
* More than 10-fold increase in BCR/ABL mRNA levels by quantitative polymerase chain reaction (Q-PCR) with at least 1 month between 2 sequential tests
* Experienced adverse events during treatment with imatinib mesylate that precluded further administration of the drug
* No CNS disease refractory to intrathecal chemotherapy
* HLA identical related donor available
* Phenotypically matched at HLA-A, -B, -C, DRQ1, and DBQ1
* No presence of circulating leukemic blasts by standard pathology
PATIENT CHARACTERISTICS:
Age
* Any age
Performance status
* Karnofsky 70-100% OR
* Lansky 70-100%
Life expectancy
* Not specified
Hematopoietic
* See Disease Characteristics
Hepatic
* No fulminant liver failure
* No cirrhosis of the liver with evidence of portal hypertension or bridging fibrosis
* No alcoholic hepatitis
* No esophageal varices
* No history of bleeding esophageal varices
* No hepatic encephalopathy
* No uncorrectable hepatic synthetic dysfunction evidenced by prolongation of PT
* No ascites related to portal hypertension
* No bacterial or fungal liver abscess
* No biliary obstruction
* No chronic viral hepatitis AND bilirubin \> 3 mg/dL
* No symptomatic biliary disease
Renal
* Renal failure allowed
Cardiovascular
* No symptomatic coronary artery disease
* Ejection fraction ≥ 35%
* No other cardiac failure requiring therapy
* No poorly controlled hypertension (blood pressure ≥ 150/90 mm Hg) on standard medication
Pulmonary
* DLCO ≥ 30%
* Total lung capacity ≥ 30%
* FEV\_1 ≥ 30%
* No requirement for continuous supplementary oxygen
* No fungal pneumonia with radiological progression after treatment with amphotericin or mold-active azoles for \> 1 month
Other
* Not pregnant or nursing
* Fertile patients must use effective barrier contraception during and for 12 months after completion of study treatment
* HIV negative
* No other disease that severely limits life expectancy
* No other active malignancy except localized nonmelanoma skin cancer
* No nonhematologic malignancy within the past 5 years that is currently in complete remission and has a \> 20% risk of disease recurrence except for nonmelanoma skin cancer
* No systemic uncontrolled infection
* No active bacterial or fungal infection unresponsive to medical therapy
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Disease Characteristics
Chemotherapy
* See Disease Characteristics
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* At least 48 hours since prior imatinib mesylateReferences
Publications (1)
- DERIVEDCooper JP, Storer BE, Granot N, Gyurkocza B, Sorror ML, Chauncey TR, Shizuru J, Franke GN, Maris MB, Boyer M, Bruno B, Sahebi F, Langston AA, Hari P, Agura ED, Lykke Petersen S, Maziarz RT, Bethge W, Asch J, Gutman JA, Olesen G, Yeager AM, Hubel K, Hogan WJ, Maloney DG, Mielcarek M, Martin PJ, Flowers MED, Georges GE, Woolfrey AE, Deeg JH, Scott BL, McDonald GB, Storb R, Sandmaier BM. Allogeneic hematopoietic cell transplantation with non-myeloablative conditioning for patients with hematologic malignancies: Improved outcomes over two decades. Haematologica. 2021 Jun 1;106(6):1599-1607. doi: 10.3324/haematol.2020.248187. PMID 32499241