A Phase 2 Study of Clofarabine, Idarubicin, Cytarabine, Vincristine, and Corticosteroids - Mixed Phenotype Acute Leukemia (MPAL)
Information source: M.D. Anderson Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Leukemia
Intervention: Clofarabine (Drug); Idarubicin (Drug); Cytarabine (Drug); Vincristine (Drug); Rituximab (Drug); Dexamethasone (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: M.D. Anderson Cancer Center Official(s) and/or principal investigator(s): Elias Jabbour, MD, Principal Investigator, Affiliation: M.D. Anderson Cancer Center
Overall contact: Elias Jabbour, MD, Phone: 713-792-4764
Summary
The goal of this clinical research study is to learn if the combination of clofarabine,
idarubicin, cytarabine, vincristine, and dexamethasone, with or without rituximab, can help
to control mixed phenotype acute leukemia. The safety of this combination will also be
studied.
Clinical Details
Official title: A Phase 2 Study of Clofarabine, Idarubicin, Cytarabine, Vincristine, and Corticosteroids for Patients With Newly Diagnosed or Relapsed Mixed Phenotype Acute Leukemia
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Response Rate
Detailed description:
Study Drug Administration:
The study drugs will be given in what are called cycles. Each cycle is 28 days.
Induction:
The first cycle of study drugs is called Induction. If the doctor thinks it is needed, you
will have up to 2 Induction cycles. During Induction cycles, you will receive:
- Clofarabine by vein over about 60 minutes on Days 1-4. If the doctor thinks it is in
your best interest, you will only receive it on Days 1-3.
- Idarubicin by vein over about 30-60 minutes on Days 1-3, about 1-2 hours after you
receive clofarabine. If the doctor thinks it is in your best interest, you will only
receive it on Days 1 and 2.
- Cytarabine by vein over about 2 hours on Days 1-4, about 3-6 hours after you receive
clofarabine.
- Vincristine by vein over about 15-30 minutes on Days 1, 8, and 15.
- Dexamethasone by vein over about 10-30 minutes on Days 1-4 and 15-18. If you have a
certain type of leukemia and the doctor thinks it is in your best interest, you will
also receive rituximab by vein over about 4-6 hours on Days 1 and 11. The study staff
will tell you if you will receive rituximab.
If the doctor thinks it is in your best interest, your dose will be reduced after Induction.
Consolidation:
If the disease responds to the study drugs during Induction, you may receive up to 6 more
cycles of study drugs. This is called Consolidation. During Consolidation cycles, you will
receive:
- Clofarabine by vein over about 60 minutes on Days 1-3. If the doctor thinks it is in
your best interest, you will only receive it on Days 1-2.
- Idarubicin by vein over about 30-60 minutes on Days 1-2, about 1-2 hours after you
receive clofarabine.
- Cytarabine by vein over about 2 hours on Days 1-3, about 3-6 hours after you receive
clofarabine. If the doctor thinks it is in your best interest, you will only receive
it on Days 1 and 2.
- Vincristine by vein over about 15-30 minutes on Days 1, 8, and 15.
- Dexamethasone by vein over about 10-30 minutes on Days 1-4 and 15-18.
- If you have a certain type of leukemia and the doctor thinks it is in your best
interest, you will also receive rituximab in Consolidation Cycles 1-3, by vein over
about 4-6 hours on Days 1 and 11. The study staff will tell you if you will receive
rituximab.
Study Visits:
Before each cycle, you will have a physical exam.
Every 3-7 days, blood (about 2-3 teaspoons) will be drawn for routine tests.
At the end of every cycle (+/- 7 days), you will have a bone marrow aspirate/biopsy
collected to check the status of the disease and for cytogenetic testing.
If the disease appears to get better, you will have these study visits less often. Blood
will be drawn every 7-14 days, and you will only have a bone marrow aspirate/biopsy when the
study doctor thinks it is needed.
Length of Study:
You may continue receiving the study drugs for 1-2 induction cycles and then up to 6
consolidation cycles. You will no longer be able to receive the study drugs if the disease
gets worse, if intolerable side effects occur, or if you are unable to follow study
directions.
Your participation on the study will be over after you have completed the end-of-study
visit, unless you will have maintenance treatment as discussed by you and the study doctor.
End-of-Study Visit:
You will have an end-of-study visit about 30 days after you stop receiving the study drugs.
At this visit, the following tests and procedures will be performed:
- You will have a physical exam.
- Blood (about 2-3 teaspoons) will be drawn for routine tests.
- If the study doctor thinks it is needed, you will have a bone marrow aspirate and/or
biopsy.
- If you can become pregnant, you will have a urine pregnancy test.
This is an investigational study. Clofarabine is FDA approved and commercially available to
treat acute lymphoblastic leukemia (ALL) in children. Idarubicin and cytarabine are FDA
approved and commercially available to treat acute myeloid leukemia (AML). Rituximab is FDA
approved and commercially available to treat various types of lymphoma and leukemia. The
use of these drugs in combination with vincristine and dexamethasone to treat mixed
phenotype acute leukemia is investigational.
The study doctor can explain how the drugs are designed to work.
Up to 60 participants will be enrolled in this study. All will take part at MD Anderson.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Sign an informed consent document
2. Age 18 to 65.
3. Newly diagnosed or relapsed MPAL, which for this protocol, will be defined as
follows: - Bone marrow result interpreted by the reading Pathologist (or tissue biopsy
for cases of extramedullary disease) as: biphenotypic leukemia, bilineal leukemia,
undifferentiated leukemia, mixed lineage leukemia, leukemia of ambiguous lineage,
T/Myeloid leukemia, B/Myeloid leukemia, or other diagnosis indicating the presence of
multiple lineages within the cell population.
4. ECOG Performance Status of = 3 at study entry.
5. Adequate organ function as outlined below (unless due to leukemia), Serum creatinine
= 3 mg/dL, Total bilirubin = 2. 5 mg/dL, ALT (SGPT) and/or AST (SGOT) = 3 x ULN
or = 5 x ULN if related to disease
6. Women of childbearing potential must have a negative serum or urine pregnancy test
within 7 days. Women of childbearing potential and men must agree to use
contraception at study entry and for the duration of active study treatment.
7. Cardiac ejection fraction >/= 40% (by either cardiac echo or MUGA scan).
Documentation of recent (= 6 months from screening) outside reports is acceptable.
8. If newly diagnosed, prior therapy with hydrea and/or steroid and the use of a single
or a two day dose of cytarabine (up to 3 g/m2), for emergency use up to 24 hours
prior to start of study therapy is allowed.
Exclusion Criteria:
1. Breast feeding females
2. Patients with active, uncontrolled infections
3. Patients with active secondary malignancy will not be eligible unless approved by the
Principal Investigator.
Locations and Contacts
Elias Jabbour, MD, Phone: 713-792-4764
University of Texas MD Anderson Cancer Center, Houston, Texas 77030, United States; Recruiting
Additional Information
University of Texas MD Anderson Cancer Center Website
Starting date: October 2014
Last updated: March 5, 2015
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