Leukemia Clinical Trial
Official title:
Phase I/II Study of Decitabine (DAC) Followed by Clofarabine, Idarubicin, and Cytarabine (CIA) in Acute Leukemia
Verified date | May 2019 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of Phase I of this clinical research study is find the highest tolerable dose of
clofarabine that can be given with decitabine, idarubicin, and cytarabine to patients with
acute leukemia.
The goal of Phase II of this study is to learn if decitabine followed by the combination of
clofarabine, idarubicin, and cytarabine can help to control acute leukemia. The safety of
this drug combination will also be studied.
Decitabine and idarubicin are designed to damage the DNA (the genetic material of cells).
This may cause cancer cells to die.
Clofarabine is designed to interfere with the growth and development of cancer cells.
Cytarabine is designed to insert itself into DNA and stop the DNA from repairing itself.
Status | Completed |
Enrollment | 65 |
Est. completion date | January 11, 2018 |
Est. primary completion date | January 11, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 64 Years |
Eligibility |
Inclusion Criteria: 1. Sign an IRB-approved informed consent document. 2. Age >/= 18 years and <65 years. 3. Diagnosis of AML [other than acute promyelocytic leukemia] with refractory/relapsed disease (Patients must be primary refractory, in relapse 1, or in relapse 2). NOTE: Patients with AML arising from prior MDS or MPN would be eligible even if they have not received treatment for the AML. NOTE: Patients with relapsed/refractory ALL would also be eligible for the phase II part of the study. NOTE: Use of hydroxyurea and/or up to 4 doses of cytarabine, for emergent cytoreduction is allowed 4. ECOG performance status of </=2 at study entry. 5. Organ function as defined below (unless due to leukemia):Serum creatinine </= 3 mg/dL;Total bilirubin </= 2.5 mg/dL; ALT (SGPT) </= 3 x ULN or </= 5 x ULN if related to disease 6. Cardiac ejection fraction = 40% (by either cardiac ECHO or MUGA scan) 7. Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential. Exclusion Criteria: 1. Breast feeding women 2. Patients with uncontrolled active infections (viral, bacterial, and fungal are not eligible). 3. Patients with active secondary malignancy will not be eligible unless approved by the PI. 4. NOTE: Prior therapy with decitabine, clofarabine, idarubicin, or cytarabine is allowed, unless the prior therapy is identical to the schema/schedule proposed in this study |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas MD Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum Tolerated Dose (MTD) of Clofarabine | Maximum tolerated dose (MTD) defined as the highest dose schedule in which 6 patients were treated with at most 1 experiencing a dose-limiting toxicity (DLT). Clofarabine 15 mg/m2 IV over approximately 1 hour daily (number of days selected based on Phase I portion). | After second, 33 day cycle | |
Primary | Number of Participants With a Response | Primary endpoint is overall response defined as the best response either complete response, complete remission without platelet recovery, or complete remission without incomplete blood count recovery within 56 days. | 56 days | |
Secondary | To Determine the Disease-free Survival (DFS). | Time from date of treatment start until the date of first objective documentation of return of disease. | Up to 2 years after participants off study date | |
Secondary | Overall Survival | Time from date of treatment start until date of death due to any cause or last Follow-up. | Up to 2 years after participants off study date |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05691608 -
MoleculAr Profiling for Pediatric and Young Adult Cancer Treatment Stratification 2
|
N/A | |
Recruiting |
NCT04092803 -
Virtual Reality as a Distraction Technique for Performing Lumbar Punctures in Children and Young Adu
|
N/A | |
Active, not recruiting |
NCT02530463 -
Nivolumab and/or Ipilimumab With or Without Azacitidine in Treating Patients With Myelodysplastic Syndrome
|
Phase 2 | |
Completed |
NCT00948064 -
Vorinostat in Combination With Azacitidine in Patients With Newly-Diagnosed Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS)
|
Phase 2 | |
Completed |
NCT04474678 -
Quality Improvement Project - "My Logbook! - I Know my Way Around!"; ("Mein Logbuch - Ich Kenne Mich Aus!")
|
N/A | |
Terminated |
NCT00801931 -
Double Cord Blood Transplant for Patients With Malignant and Non-malignant Disorders
|
Phase 1/Phase 2 | |
Recruiting |
NCT03948529 -
RevErsing Poor GrAft Function With eLtrombopag After allogeneIc Hematopoietic Cell trAnsplantation
|
Phase 2 | |
Completed |
NCT01682226 -
Cord Blood With T-Cell Depleted Haplo-identical Peripheral Blood Stem Cell Transplantation for Hematological Malignancies
|
Phase 2 | |
Completed |
NCT00003270 -
Chemotherapy, Radiation Therapy, and Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer
|
Phase 2 | |
Active, not recruiting |
NCT02723994 -
A Phase 2 Study of Ruxolitinib With Chemotherapy in Children With Acute Lymphoblastic Leukemia
|
Phase 2 | |
Terminated |
NCT02469415 -
Pacritinib for Patients With Lower-Risk Myelodysplastic Syndromes (MDS)
|
Phase 2 | |
Recruiting |
NCT04856215 -
90Y-labelled Anti-CD66 ab in Childhood High Risk Leukaemia
|
Phase 2 | |
Recruiting |
NCT06155188 -
Post-transplant PT/FLU+CY Promotes Unrelated Cord Blood Engraftment in Haplo-cord Setting in Childhood Leukemia
|
N/A | |
Completed |
NCT00001637 -
Immunosuppressive Preparation Followed by Blood Cell Transplant for the Treatment of Blood Cancers in Older Adults
|
Phase 2 | |
Active, not recruiting |
NCT04188678 -
Resiliency in Older Adults Undergoing Bone Marrow Transplant
|
N/A | |
Completed |
NCT02910583 -
Ibrutinib Plus Venetoclax in Subjects With Treatment-naive Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma (CLL/SLL)
|
Phase 2 | |
Completed |
NCT01212926 -
Early Detection of Anthracycline Cardiotoxicity by Echocardiographic Analysis of Myocardial Deformation in 2D Strain
|
N/A | |
Terminated |
NCT00014560 -
Antibody Therapy in Treating Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
|
Phase 1 | |
Recruiting |
NCT04977024 -
SARS-CoV-2 Vaccine (GEO-CM04S1) Versus mRNA SARS-COV-2 Vaccine in Patients With Blood Cancer
|
Phase 2 | |
Recruiting |
NCT05866887 -
Insomnia Prevention in Children With Acute Lymphoblastic Leukemia
|
N/A |