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Clofarabine, Cyclophosphamide and Etoposide for Minimal Residual Disease Positive Acute Leukemia | Clinical Trials | Clareo Health

WITHDRAWNPHASE2

Clofarabine, Cyclophosphamide and Etoposide for Minimal Residual Disease Positive Acute Leukemia

A Phase II Trial Investigating Clofarabine, Cyclophosphamide and Etoposide for Minimal Residual Disease Positive Acute Leukemia

NCT01677949•Masonic Cancer Center, University of Minnesota

View on ClinicalTrials.gov

Summary

Study Design: This is a two-stage Phase II trial investigating the efficacy of Clofarabine, Cyclophosphamide and Etoposide in acute leukemia patients with detectable minimal residual disease (MRD) prior to allo-HCT. The primary objective is to determine the impact of the study treatment in eliminating the presence of minimal residual disease without causing a significant delay of allo-HCT due to treatment related toxicity. The intent of this study is to allow patients to proceed to transplant (independent of this study) within 42 days of Day 1 of Clofarabine based therapy.

Detailed Description

Patients will be stratified at the time of enrollment based on diagnosis (ALL versus AML). Based on this two-stage optimal design, a maximum of 49 patients with ALL and a maximum of 49 patients with AML will be needed. For each disease cohort, 21 patients will be enrolled in stage 1. If at the end of stage 1, the criteria is met for activating stage 2 (based on success of clearing MRD, proceeding to transplant within 42 days and without excessive toxicity) for one or both groups, stage 2 will be activated with an additional 28 patients enrolled.

Eligibility

Age

0 - 60 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosis of acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML) with \<5% blasts in the bone marrow (M1) by morphology and that meets one of the following criteria:
•* Flow cytometric evidence of MRD (≥ 0.1% leukemic blasts for ALL or \<5% leukemic blasts for AML detected in the bone marrow) OR
•* Molecular/cytogenetic evidence of disease (FISH or PCR methodology) performed within 7 days
•* AND with the intent of going on to an allogeneic hematopoietic cell transplantation (allo-HCT) independent of this study
•Age 0 to 60 years
•Karnofsky Performance Status ≥ 50% for patients 16 years and older and Lansky Play Score ≥ 50 for patients under 16 years of age
•Patients must have a life expectancy ≥ 8 weeks as determined by the enrolling investigator
•Have acceptable organ function as defined within 7 days of study registration:
•* Renal: creatinine clearance ≥70mL/min/1.73m2 or serum creatinine based on age/gender
•* Hepatic: aspartate aminotransferase (ALT) \< 5 x upper limit of normal (ULN) and total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age
+5 more criteria

Exclusion Criteria

•Acute Promyelocytic Leukemia (APL)
•Active central nervous system (CNS) leukemia or known chloromatous disease
•Receiving or plans to receive concomitant chemotherapy, radiation therapy; immunotherapy or other anti-cancer therapy other than is specified in the protocol
•Systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
•Pregnant or lactating. The agents used in this study are known to be teratogenic to a fetus and there is no information on the excretion of agents into breast milk. All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy.
•Known allergy to any of the agents or their ingredients used in this study

Locations (1)

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, United States

Key Dates

Start Date

December 1, 2013

Primary Completion Date

January 1, 2016

Completion Date

January 1, 2016

Last Updated

December 2, 2017

Conditions

Acute Myeloid LeukemiaAcute Lymphoblastic Leukemia

Interventions

Clofarabine

DRUG

Etoposide

DRUG

Cyclophosphamide

DRUG

allogeneic hematopoietic cell transplantation

BIOLOGICAL

Phase I Study of HC-7366 for Acute Myeloid Leukemia

NCT06285890

Acute Myeloid Leukemia

View study

RECRUITINGPHASE2

Study of Venetoclax Combined With Azacitidine Regimen in Newly Diagnosed T-ALL Patients

NCT05376111

T-cell Acute Lymphoblastic LeukemiaRecruiting

View study

RECRUITINGPHASE2

VAC Regimen for AML Patients Who Failed to Response to VA Regimen

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 2, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Clofarabine, Cyclophosphamide and Etoposide for Minimal Residual Disease Positive Acute Leukemia

Inclusion Criteria

Exclusion Criteria

Phase I Study of HC-7366 for Acute Myeloid Leukemia

Study of Venetoclax Combined With Azacitidine Regimen in Newly Diagnosed T-ALL Patients

VAC Regimen for AML Patients Who Failed to Response to VA Regimen

A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation

Phase III Study of Induction and Consolidation Chemotherapy With Venetoclax in Patients With Newly Diagnosed AML or MDS-EB-2

A Study of CBX-250 in Participants With Relapsed or Refractory Myeloid Leukemias