Clofarabine and Cyclophosphamide in Treating Patients With Relapsed or Refractory Acute Leukemia,… (NCT00293410) | Clinical Trial Compass
CompletedPhase 1
Clofarabine and Cyclophosphamide in Treating Patients With Relapsed or Refractory Acute Leukemia, Chronic Myelogenous Leukemia, or Myeloproliferative Disorders
United States70 participantsStarted 2005-11
Plain-language summary
RATIONALE: Drugs used in chemotherapy, such as clofarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of clofarabine and cyclophosphamide in treating patients with relapsed or refractory acute leukemia, chronic myelogenous leukemia, or myeloproliferative disorders.
Who can participate
Age range
2 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Histologically confirmed leukemia or myeloproliferative disorders, including 1 of the following:
* Acute myeloid leukemia (AML) of any subtype
* Treatment-related AML OR AML evolving from myeloproliferative disorders (MPD) or transformed from myelodysplastic syndrome
* Acute lymphocytic leukemia
* Acute progranulocytic leukemia
* Must not be eligible for arsenic or retinoic acid therapy
* Chronic myelogenous leukemia in accelerated phase or blast crisis
* High-risk MPD, including any of the following:
* Myelofibrosis
* Chronic myelomonocytic leukemia with 5%-19% blasts
* Relapsed or refractory juvenile myelomonocytic leukemia
* Relapsed and/or refractory disease with progressive disease since last therapy
* No more than 3 prior induction regimens with cytotoxic agents for adults
* Must be in second relapse for patients \< 21 years of age
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2 (for adults) OR Lansky 50-100% (for pediatric patients)
* Bilirubin ≤ 1.5 mg/dL (may be elevated due to hemolysis in adult patients)
* AST and ALT ≤ 5 times upper limit of normal
* Creatinine ≤ 2.0 mg/dL (for adults)
* Normal renal function (for pediatric patients)
* Cardiac function normal as measured by MUGA scan or echocardiogram
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception during and for at least 6 months after completion of study treatment
* HIV nega…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 1 trial combining clofarabine and cyclophosphamide for relapsed or refractory acute leukemia or myeloproliferative disorders — since Phase 1 studies are primarily designed to find a safe dose rather than prove the treatment works, what does that mean for my realistic expectations about benefit versus risk?
2The trial has already completed enrollment, so I can't join it — but based on whatever results or safety data have come out of this study, does the clofarabine-plus-cyclophosphamide combination look promising enough to be relevant to my specific situation?
3Since this trial targeted patients whose disease had already relapsed or stopped responding to prior treatment, does my current treatment history match that profile, and how does that affect which options my doctor would recommend for me now?
4Both clofarabine and cyclophosphamide are intensive chemotherapy agents — based on what this trial found about side effects or toxicity at different doses, are there safety signals my doctor thinks I should weigh against other available treatments?
5Are there currently open trials or standard treatments building on what this completed study found that might be a better fit for me than what was being tested here?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Trial details
NCT IDNCT00293410
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins