Leukemia, Myeloid, Chronic Clinical Trial
Official title:
Randomized Trial of Therapy of Early Phase Chronic Myelogenous Leukemia With High-Dose Imatinib Mesylate (Gleevec) Alone or in Combination With Peg-Alpha Interferon (PEG-Intron) and Sargramostim (GM-CSF)
Verified date | August 2015 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The goal of this clinical research study is to learn if giving PEG-Alpha Interferon (PEG-Intron) and Sargramostim (GM-CSF) to patients receiving treatment with high dose Gleevec (imatinib mesylate) is more effective in treating CML in chronic phase than therapy with imatinib mesylate alone.
Status | Completed |
Enrollment | 94 |
Est. completion date | August 2015 |
Est. primary completion date | April 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Patients with Ph-positive CML in early chronic phase CML who have received no or minimal prior therapy, (<1 month of prior IFN-alpha (with or without ara-C) and/or Gleevec). 2. Eastern Cooperative Oncology Group (ECOG) performance of 0-2. 3. Adequate end organ function, defined as the following: total bilirubin < 1.5 x upper limit of normal (ULN), serum glutamate pyruvate transaminase (SGPT) < 2.5 x ULN, creatinine < 1.5 x ULN 4. Signed informed consent. Exclusion Criteria: 1. New York Heart Association (NYHA) cardiac class 3-4 heart disease. 2. Psychiatric disability (psychosis) 3. Pregnant or lactating females 4. Late chronic phase, accelerated or blastic phase |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Texas MD Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | Novartis |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Duration of Pathological Complete Response Negativity or Cytogenetic Response | Duration measured in time from first response to disease progression; Cytogenetic (or FISH), and PCR quantification every 3-4 months as indicated in year one then FISH every 1-3 years and PCR every year | Molecular response at 12 Months and Polymerase Chain Reaction (PCR) testing once a year (+/- 3 months) | No |
Primary | Number of Participants with Complete Hematologic Remission (CHR) Classification of Complete Cytogenetic Response | Complete Hematologic Remission (CHR) - normalization >4 weeks of bone marrow (less than 5% blasts) & peripheral blood with white blood count (WBC)<10x10^9/L & no peripheral blasts, promyelocytes or myelocytes, disappearance of all signs & symptoms of disease. Partial Hematologic Response (PHR) = CHR except persistence of immature cells (myelocytes, metamyelocytes), or splenomegaly <50% of pretreatment, or thrombocytosis >450x10^9/L but <50% of pretreatment. Complete hematologic remission further classified according to suppression of Philadelphia chromosome (Ph) by cytogenetics or fluorescence in situ hybridization (FISH): a) No cytogenetic response - Ph positive 100% of pretreatment value; b) Minor cytogenetic response - Ph positive 35-90% of pretreatment value; c) Partial cytogenetic response - Ph positive 1-34% of pretreatment value; d) Complete cytogenetic response - Ph positive 0%. | Molecular response at 12 Months | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT00393380 -
Study of Parathyroid Hormone Following Sequential Cord Blood Transplantation From an Unrelated Donor
|
Phase 2 | |
Completed |
NCT00186342 -
Sibling and Unrelated Donor Hematopoietic Cell Transplant in Hematologic Malignancies
|
N/A | |
Completed |
NCT00759837 -
Study Evaluating The Pharmacokinetics (PK) And Safety Of Bosutinib In Subjects With Liver Disease And In Healthy Subjects
|
Phase 1 | |
Completed |
NCT00538109 -
An Open-Label, Multicenter, Expanded Access Study of Oral AMN 107 in Adult Patients With Imatinib (Glivec®/Gleevec®_ - Resistant or Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase
|
N/A | |
Completed |
NCT00040105 -
Zarnestra and Gleevec in Chronic Phase Chronic Myelogenous Leukemia
|
Phase 1 | |
Terminated |
NCT00176930 -
Stem Cell Transplant for Hematological Malignancy
|
N/A | |
Recruiting |
NCT01015742 -
Unrelated Double Umbilical Cord Blood Units Transplantation
|
Phase 2/Phase 3 | |
Completed |
NCT00406393 -
Sirolimus/Tacrolimus Versus Tacrolimus/Methotrexate for Preventing Graft-Versus-Host Disease (GVHD) (BMT CTN 0402)
|
Phase 3 | |
Completed |
NCT00246662 -
Safety Assessment of Two Schedules of Intravenous Infusions of SNS-595 for the Treatment of Hematologic Malignancies
|
Phase 1 | |
Completed |
NCT00264160 -
Efficacy and Safety of Oral AMN107 in Adults With Chronic Myelogenous Leukemia Resistant and/or Intolerant to Imatinib Mesylate Therapy
|
Phase 2/Phase 3 | |
Terminated |
NCT00306332 -
T-cell and B-cell Depletion in Allogeneic Peripheral Blood Stem Cell Transplantation
|
Phase 3 | |
Terminated |
NCT00058747 -
AG-858 in Patients Who Are Cytogenetically Positive After Treatment With Gleevecâ„¢
|
Phase 2 | |
Active, not recruiting |
NCT00538447 -
Prospective Database for Chronic Myelogenous Leukemia
|
N/A | |
Terminated |
NCT01050946 -
Hematopoietic Stem Cell Transplantation (HSCT) Using CD34 Selected Mismatched Related Donor and One Umbilical Cord Unit
|
Phase 2 | |
Completed |
NCT00034684 -
Study of Farnesyl Protein Transferase Inhibitor (FPTI) in Patients With Leukemia (Study P00701)
|
Phase 1/Phase 2 | |
Recruiting |
NCT04260022 -
Study of HQP1351 in Subjects With Refractory CML and Ph+ ALL
|
Phase 1 | |
Terminated |
NCT00167180 -
Post Transplant Donor Lymphocyte Infusion
|
Phase 2 | |
Terminated |
NCT00449761 -
Efficacy and Safety of LBH589B in Adult Patients With Refractory Chronic Myeloid Leukemia in Accelerated or Blast Phase
|
Phase 2 | |
Completed |
NCT00455221 -
Safety Assessment of a Multipeptide-gene Vaccine in CML
|
Phase 1 | |
Completed |
NCT00298987 -
A Study of Dasatinib in Patients With Chronic Myelogenous Leukemia Who Are Resistant or Intolerant of Imatinib Mesylate
|
Phase 2 |