Clinical trial · Interventional
Interferon and GM-CSF Compared With Imatinib Mesylate and Vaccine Therapy in Patients With Chronic Phase CML on a TKI
A Randomized Phase II Trial of Interferon + GM-CSF Versus K562/GM-CSF Vaccination in CML Patients Achieving a Complete Cytogenetic Response to Frontline Tyrosine Kinase Inhibitor Therapy
- 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: Tyrosine kinase inhibitors may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Interferon alfa may interfere with the growth of cancer cells. GM-CSF may help cells that are involved in the body's immune response work better. Vaccines made from a person's cancer cells may help the body build an effective immune response to kill cancer cells. PURPOSE: This randomized phase II trial is studying tyrosine kinase inhibitors, interferon alfa, and GM-CSF to see how well they work compared to tyrosine kinase inhibitors and vaccine therapy in treating patients with chronic 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GM-K562 cell vaccine | Biological | — | UNRESOLVED |
| Interferon alfa | Biological | — | UNRESOLVED |
| Sargramostim | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- Patients will receive injections of interferon alfa and sargramostim once a day for 6 months. Some patients may receive treatment for up to 1 year. After 1 year, some patients may receive treatment as in arm II.
- interventionNames
- Biological: Interferon alfa
- Biological: Sargramostim
- type
- EXPERIMENTAL
- label
- Arm B
- description
- Patients will receive an injection of GM-K562 cell vaccine every 3 weeks for at least 6 months. Some patients may receive treatment for up to 1 year. After 1 year, some patients may receive treatment as in arm I. NOTE: Study Arm B is not available to newly accrued and enrolled subjects based on the interim analysis directing all new subjects to the combination of Interferon + sargramostim (Arm A).
- interventionNames
- Biological: GM-K562 cell vaccine
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of chronic myelogenous leukemia (CML) in chronic phase based on cytogenetic detection of the Philadelphia chromosome and/or detection of the BCR-ABL rearrangement by any of the following molecular methods: * Recombinant DNA analysis of the BCR-ABL fusion gene * Fluorescence in situ hybridization (FISH) * Polymerase chain reaction detection of the BCR-ABL hybrid mRNA * Documentation of complete cytogenetic response by conventional cytogenetic or FISH analysis while on a stable dose of tyrosine kinase inhibitor * No other phase of CML PATIENT CHARACTERISTICS: * ECG performance status 0-2 * Life expectancy \> 24 months * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception * Creatinine ≤ 2.0 mg/dL * Bilirubin ≤ 2.0 times upper limit of normal (ULN) * AST and ALT ≤ 2.5 times ULN * No other malignancy within the past 5 years except in situ cervical carcinoma or adequately treated nonmelanoma skin cancer * No other disease requiring long-term corticosteroids or immunosuppressants PRIOR CONCURRENT THERAPY: * At least 28 days since prior investigational agents * No prior bone marrow transplant or other transplant * No concurrent immunosuppressants (e.g., steroids, cyclosporine, azathioprine, mycophenolate mofetil, sirolimus, or tacrolimus) * No concurrent hydroxyurea, busulfan, or cytoreductive agents (other than frontline TKI) * No other concurrent anticancer agents or therapies
References
Publications (0)
Data not yet available