Plerixafor and Clofarabine in Frontline Treatment of Elderly Patients With Acute Myelogenous Leukemia (AML)
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|ClinicalTrials.gov Identifier: NCT01160354|
Recruitment Status : Terminated (Slow Accrual)
First Posted : July 12, 2010
Results First Posted : May 10, 2019
Last Update Posted : May 10, 2019
The goal of Part 1 of this clinical research study is to learn about the safety of the combination of plerixafor and clofarabine when given to patients with previously untreated AML who are at least 60 years old.
The goal of Part 2 of this study is to learn if the combination of plerixafor and clofarabine can help to control previously untreated AML in patients who are at least 60 years old. Study was closed early and did not progress to Part 2.
|Condition or disease||Intervention/treatment||Phase|
|Acute Myelogenous Leukemia||Drug: Plerixafor Drug: Clofarabine||Phase 1 Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study of Plerixafor and Clofarabine in Previously Untreated Older (>/=60 Years) Adult Patients With Acute Myelogenous Leukemia (AML) With Two or More Unfavorable Prognostic Factors for Whom Standard Induction Chemotherapy is Unlikely to be of Benefit|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||March 2016|
Experimental: Plerixafor + Clofarabine
Phase I: Plerixafor starting at 240 mcg/kg daily subcutaneous (SQ) injection on Days 1-5, 4-6 hours before a 1 hour (+/- 30 minutes) IV administration of Clofarabine.
Phase II: Plerixafor at the highest dose tolerated in Phase I.
Phase I and II: Clofarabine fixed dose of 30 mg/m2/day during Induction cycle (20 mg/m2/day in consolidation cycles).
Starting at 240 mcg/kg daily subcutaneous (SQ) injection on Days 1-5, 4-6 hours before a 1 hour (+/- 30 minutes) IV administration of Clofarabine
Other Name: Mobozil
Fixed dose of 30 mg/m2/day during Induction cycle (20 mg/m2/day in consolidation cycles).
- Number of Participants in Phase I With First Cycle Dose Limiting Toxicities (DLT) Observed [ Time Frame: First cycle of treatment, i.e. first 4 weeks on study ]Dose limiting toxicity (DLT) consists of participants who developed DLT during maximum tolerated dose (MTD) estimation period where DLTs observed during dose escalation were used to develop MTD. The MTD is the highest dose level in which <2 participants of 6 develop first cycle. DLT. Toxicity graded according to the NCI Common Toxicity Criteria Version 3.0. The timeframe to assess dose-limiting toxicities (DLT's) will be the first cycle of treatment, i.e. the first 4 weeks on study. The Plerixafor dose to be used in Phase II of the protocol is the highest dose at which no more than 1 of 6 patients experience a DLT in the Phase I part of the protocol or a lower dose selected at the end of dose escalation.
- Participants' Response During First Part of Study [ Time Frame: Assessments following 3 cycles (at 12 weeks) up to 5 cycles (20 weeks) ]Response defined as Complete remission (CR): Disappearance all clinical +/or radiologic evidence disease. Neutrophil count >/=1.0x10^9/L & platelet count >/=100x10^9/L, & normal bone marrow differential (</= 5% blasts). Complete Remission without Platelet Recovery (CRp): Peripheral blood & bone marrow results as for CR, but with platelet counts of <100x10^9/L. Partial Remission (PR): Blood count recovery as for CR, but both decrease in marrow blasts >50% & not more than 6 to 25% abnormal cells in the marrow.
- Number of Participants With Overall Response During Second Part of Study [ Time Frame: Continuously monitored, assessments at 12 weeks ]Overall response (OR) = Complete Remission (CR) + Partial Remission (PR) where response defined: Complete remission (CR): Disappearance all clinical +/or radiologic evidence disease. Neutrophil count >/=1.0x109/L & platelet count >/=100x10^9/L, & normal bone marrow differential (</= 5% blasts). Complete Remission without Platelet Recovery (CRp): Peripheral blood & bone marrow results as for CR, but with platelet counts of <100x10^9/L. Partial Remission (PR): Blood count recovery as for CR, but both decrease in marrow blasts >50% & not more than 6 to 25% abnormal cells in the marrow. Treatment Failure: For purposes of efficacy analysis of remission, less than a CR, CRi, or PR categorized as Treatment Failure.
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): NCT01160354
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||Jan A. Burger, MD||M.D. Anderson Cancer Center|