Donor Cellular Therapy After Cytarabine in Treating Patients With Intermediate-Risk Acute Myeloid Leukemia in Remission
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02587871|
Recruitment Status : Withdrawn (PI decided not to pursue study)
First Posted : October 27, 2015
Last Update Posted : November 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Adult Acute Myeloid Leukemia in Remission Childhood Acute Myeloid Leukemia in Remission||Drug: Cytarabine Other: Laboratory Biomarker Analysis Procedure: Peripheral Blood Stem Cell Transplantation Biological: Therapeutic Allogeneic Lymphocytes Biological: G-CSF mobilized peripheral blood cells||Phase 2|
I. To assess 2-year disease-free survival (as defined by time to death from any cause or disease relapse, whichever is earlier) for patients < 60 years of age with intermediate-risk acute myeloid leukemia (AML), in complete remission (CR) after induction chemotherapy, who receive microtransplantation, compared to patients who received consolidation chemotherapy only in a historical published comparable cohort of patients.
I. To obtain estimates of rate of relapse, treatment related mortality (TRM), all cause mortality, in the microtransplantation (MST) group and compare it with allogeneic stem cell group (historical cohort).
II. To obtain estimates of rate acute graft-versus-host disease (GVHD), chronic GVHD, time to recovery of absolute neutrophil counts and platelets in patients with intermediate risk AML receiving of chemotherapy in combination with microtransplantation.
I. Presence or absence of detectable donor chimerism post-microtransplantation until 6 months after the last infusion.
II. Characteristics of the infused cells and composition of the graft. III. Dynamics of T-cell clonality. IV. Immune cell subset analysis.
Approximately 4-6 weeks after completion of induction chemotherapy, patients receive cytarabine intravenously (IV) over 1-3 hours twice daily (BID) on days -7 to -2 and granulocyte colony stimulating factor (G-CSF) mobilized peripheral blood cells (microtransplant) IV over 15-20 minutes on day 0. Treatment repeats every 8-10 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at least every 3 months for 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||HLA-Mismatched Allogeneic Cellular Therapy (Microtransplantation) After Chemotherapy in Patients With Intermediate-Risk Acute Myeloid Leukemia < 60 Years|
|Estimated Study Start Date :||December 12, 2018|
|Estimated Primary Completion Date :||November 12, 2020|
|Estimated Study Completion Date :||November 12, 2022|
Experimental: Treatment (cytarabine, G-CSF mobilized peripheral blood cells)
Approximately 4-6 weeks after completion of induction chemotherapy, patients receive cytarabine IV over 1-3 hours BID on days -7 to -2 and G-CSF mobilized peripheral blood cells (microtransplant) IV over 15-20 minutes on day 0. Treatment repeats every 8-10 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Procedure: Peripheral Blood Stem Cell Transplantation
Biological: Therapeutic Allogeneic Lymphocytes
Biological: G-CSF mobilized peripheral blood cells
Other Name: Filgrastim
- Disease free survival (DFS) [ Time Frame: Beginning of therapy to the date of death or the date of last follow-upexamination, assessed at 2 years ]The 2-year DFS will be estimated, and the corresponding 90% confidence intervals will be constructed. The data will be displayed using a Kaplan-Meir curve to plot the DFS over time. Calculate bilateral 95% confidential interval of mean difference of disease-free survival rate, and compare the lower limit of the bilateral 95% confidential interval and 15% superiority boundary value.
- Cumulative incidence acute GVHD, classified as clinically significant (grades 2 to 4) or severe (grades 3 to 4) [ Time Frame: 6 months after microtransplant ]At single time point, if univariate quantitative data of the meets the normal distribution and homogeneity of variance, perform test of univariate quantitative data, otherwise, adopt the rank-sum test of corresponding design; for univariate quantitative data under multiple time points, use mixed effects model to design variance analysis with repeated measure factors.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02587871
|United States, California|
|USC / Norris Comprehensive Cancer Center|
|Los Angeles, California, United States, 90033|
|Principal Investigator:||Giridharan Ramsingh||University of Southern California|