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Acute Myeloid LeukemiaPhase 2NCT01677949

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

A Phase 2 study testing Clofarabine, Etoposide and Cyclophosphamide in people with Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 60 years
What is being tested?
Clofarabine, Etoposide and Cyclophosphamide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Dec 2013to Jan 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 60 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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
Show all 15Show fewer
  • 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
  • Cardiac: left ventricular ejection fraction ≥ 40% by echocardiogram (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 14 days must have elapsed from prior chemotherapy; at least 7 days must have elapsed since receiving biological therapy.
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Masonic Cancer Center, University of Minnesota

    Minneapolis, Minnesota, 55455

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Clofarabine, Etoposide, Cyclophosphamide, allogeneic hematopoietic cell transplantation
Medical subject headings
Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ClofarabineDrug

    Also called Clolar

    Days 1-5: Clofarabine 30 mg/m^2 for 0-30 years of age or 20 mg/m^2 for > 30 years of age intravenously (IV) over 2 hours

  • EtoposideDrug

    Also called Eposin, Etopophos, Vepesid, VP-16

    Days 1-5: Etoposide 100mg/m^2 IV over 2 hours

  • CyclophosphamideDrug

    Also called Cytoxan

    Days 1-5: Cyclophosphamide 300 mg/m^2 as a 30-60 minute infusion

  • allogeneic hematopoietic cell transplantationBiological

    Also called allo-HCT

    Between Days 28 and 42: infused independent of this study

Study groups in NCT01677949
Study groupRoleWhat they receive
ALL patients receiving transplantExperimentalPatients intent on receiving an allogeneic hematopoietic cell transplantation (allo-HCT) with the diagnosis of acute lymphoblastic leukemia (ALL) along with Clofarabine, Etoposide and Cyclophosphamide.
Receives: Drug: Clofarabine; Drug: Etoposide; Drug: Cyclophosphamide; Biological: allogeneic hematopoietic cell transplantation
AML patients receiving transplantExperimentalPatients intent on receiving an allogeneic hematopoietic cell transplantation (allo-HCT) with the diagnosis of acute myeloid leukemia (AML) along with Clofarabine, Etoposide and Cyclophosphamide.
Receives: Drug: Clofarabine; Drug: Etoposide; Drug: Cyclophosphamide; Biological: allogeneic hematopoietic cell transplantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Patients Unable to Proceed to Transplantation

    The primary endpoint of this study will be to determine the impact of Clofarabine, Cyclophosphamide and Etoposide on the conversion to an minimal residual disease (MRD) negative state at day 30 (<0.01% leukemic blasts by flow cytometry) or day 42 if day 30 marrow is un-evaluable due to hypocellularity per RECIST criteria as well as the ability of patients to reach allo-HCT without significant delay due to study treatment related toxicity. Unable to proceed to transplant by Day 42 will be considered unacceptable.

    Measured: Between Day 30 and Day 42

Secondary outcomes (5)

  1. Rate of Pre-Transplant Chemotherapy-Induced Aplasia

    defined as greater than 42 days after infusion of chemotherapy

    Measured: After Day 42

  2. Rate of Infectious Complications

    Measured: Day 1 Through Day 30

  3. Treatment-Related Mortality After Transplant

    In the field of transplantation, toxicity is high and all deaths without previous relapse or progression are usually considered as related to transplantation.

    Measured: Day 100

  4. Disease-Free Survival After Transplant

    The length of time after treatment ends that a patient survives without any signs or symptoms of that cancer or any other type of cancer. In a clinical trial, measuring the disease-free survival is one way to see how well a new treatment works.

    Measured: 1 Year

  5. Rate of Leukemic Relapse After Transplant

    The return of disease after its apparent recovery/cessation.

    Measured: Day 100

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2012 (estimated)
  2. Study startDec 2013
  3. Primary completionJan 2016
  4. Study completionJan 2016

Why it stopped: Slow accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01677949
Sponsor's protocol ID
2011LS158
Other IDs
HM2012-05
Status last verified
Apr 2016
First submitted
28 Aug 2012
Last updated
2 Dec 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Clofarabine, Etoposide and Cyclophosphamide in people with Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 2 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients Unable to Proceed to Transplantation (time frame: Between Day 30 and Day 42). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01677949.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2017.

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