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Trial record 48 of 126 for:    "Acute Leukemia" | "Antimetabolites, Antineoplastic"

Bridging Study to Eliminate Presence of MRD for Acute Leukemia Before HCT

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ClinicalTrials.gov Identifier: NCT02349178
Recruitment Status : Terminated (Low accrual)
First Posted : January 28, 2015
Results First Posted : February 12, 2019
Last Update Posted : February 12, 2019
Sponsor:
Collaborators:
American Family Children’s Hospital
Nationwide Children's Hospital
Information provided by (Responsible Party):
Michael Burke, Medical College of Wisconsin

Brief Summary:

This is a Phase 2 study designed for the purpose of estimating various parameters surrounding the efficacy of Clofarabine, Cyclophosphamide and Etoposide in eliminating minimal residual disease (MRD) in acute leukemia patients otherwise in remission and without causing significant delay of HCT due to treatment related toxicity.

A single course of "bridge" chemotherapy is given prior to the transplant procedure as an approach to improved disease-free survival in a patient group who historically has had inferior outcomes.


Condition or disease Intervention/treatment Phase
Leukemia, Acute Lymphoblastic Acute Myeloid Leukemia Drug: Clofarabine Drug: Cyclophosphamide Drug: Etoposide Phase 2

Detailed Description:

Study entry is open to patients regardless of gender or ethnic background.

The intent of this study design is for all patients to receive and complete one course of therapy. Patients who exhibit signs of disease progression or experience an unacceptable toxicity will be discontinued from treatment.

There will be no dose delays or dose reductions of study drugs for hematologic toxicity during Consolidation "Bridging" therapy (Day 1 through Day 30); however, prolonged hematopoietic recovery or bone marrow aplasia during the first 42 days may meet a study stopping rule.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bridging Study: A Phase 2 Study Investigating Clofarabine, Cyclophosphamide and Etoposide for Children, Adolescents, and Young Adults (AYA) With Acute Leukemia and Minimal Residual Disease
Actual Study Start Date : December 8, 2014
Actual Primary Completion Date : March 16, 2017
Actual Study Completion Date : March 16, 2017


Arm Intervention/treatment
Experimental: Bridging Arm
Days 1-5 Receive 20 mg/m2 IV Clofarabine (CLOLAR) over 2 hours followed by 100 mg/m2 IV Etoposide (VP-16, Etopophos) over 2 hours followed by 300 mg/m2 IV Cyclophosphamide (Cytoxan, CTX) as a 30-60 minute infusion
Drug: Clofarabine
Days 1-5 receive Clofarabine 20 mg/m2 IV over 2 hours
Other Name: CLOLAR

Drug: Cyclophosphamide
Days 1-5 receive Cyclophosphamide 300 mg/m2 IV as a 30-60 minute infusion
Other Name: Cytoxan, CTX

Drug: Etoposide
Days 1-5 receive Etoposide 100 mg/m2 IV over 2 hours
Other Name: VP-16, Etopophos




Primary Outcome Measures :
  1. Minimal Residual Disease [ Time Frame: Day 30 or adequate blood recovery ]
    A bone marrow evaluation to determine study response and remission status will be performed on study Day 30 or upon adequate blood count recovery (ANC > 0.50 and platelet > 50,000), whichever occurs first. If the marrow is hypocellular and without evidence of normal tri-lineage hematopoiesis the marrow should be repeated at Day 42.



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Ages Eligible for Study:   up to 39 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 (≥ 0.01% leukemic blasts for ALL or ≥ 0.5% 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 (HCT) independent of this study

  • Patients must have an available donor and have intention of proceeding directly to ALL-HCT after completion of 1 cycle of Bridging therapy.
  • Age 0 to 39 years
  • Karnofsky Performance Status ≥ 50% for patients 16 years and older and Lansky Play Score ≥ 50 for patients under 16 years of age (see Appendix 2)
  • 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 ≥ 60 mL/min/1.73 m2 or serum creatinine based on age/gender as follows:

Hepatic: ALT < 5 x upper limit of normal (ULN) and total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age Cardiac: left ventricular ejection fraction ≥ 40% by ECHO/MUGA

  • Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study. At least 7 days must have elapsed from prior chemotherapy.
  • Hematopoietic Growth Factors: At least 7 days since the completion of therapy with a growth factor and at least 14 days since pegfilgrastim (Neulasta®) administration.
  • Sexually active females of child bearing potential must agree to use adequate contraception (diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.) for the duration of treatment and for 2 months after the last dose of chemotherapy. Sexually active men must agree to use barrier contraceptive for the duration of treatment and for 2 months after the last dose of chemotherapy.
  • Voluntary written consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.

Exclusion Criteria:

  • Acute Promyelocytic Leukemia (APL)
  • Active extramedullary disease (CNS ≥ CNS2 and/or testicular leukemia) or presence of chloromatous disease
  • Receiving 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
  • Participating in a concomitant Phase 1 or 2 study

Information from the National Library of Medicine

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): NCT02349178


Locations
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United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 53205
United States, Wisconsin
American Family Children's Hospital
Madison, Wisconsin, United States, 53792
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
American Family Children’s Hospital
Nationwide Children's Hospital
Investigators
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Principal Investigator: Michael J Burke, MD Medical College of Wisconsin
  Study Documents (Full-Text)

Documents provided by Michael Burke, Medical College of Wisconsin:

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Responsible Party: Michael Burke, Associate Professor, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT02349178     History of Changes
Other Study ID Numbers: Bridging
First Posted: January 28, 2015    Key Record Dates
Results First Posted: February 12, 2019
Last Update Posted: February 12, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Antimetabolites, Antineoplastic
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Leukemia, Lymphoid
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Etoposide
Etoposide phosphate
Clofarabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antimetabolites