Phase 2
N=34
Interferon and GM-CSF Compared With Imatinib Mesylate and Vaccine Therapy in Patients With Chronic Phase CML on a TKI
Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT00363649 ↗Enrolled (actual)
34
Serious AEs
3.6%
Results posted
Nov 2018
Primary outcome: Primary: Progression-free Survival — 2; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- GM-K562 cell vaccine (Biological); Interferon alfa (Biological); Sargramostim (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival |
2; 0 | — |
| PRIMARY Complete Remission Rate |
61.1; 62.5 | — |
| SECONDARY Time to Complete Molecular Remission |
10; 16.3 | — |
| SECONDARY Disease-free Survival |
82; 98 | — |
| SECONDARY Early Discontinuation |
10; 0 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00363649). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.