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Ruxolitinib or Dasatinib With Chemotherapy in Patients With Philadelphia Chromosome (Ph)-Like Acute Lymphoblastic Leukemia (ALL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02420717
Recruitment Status : Recruiting
First Posted : April 20, 2015
Last Update Posted : September 14, 2018
Sponsor:
Collaborator:
Incyte Corporation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant.

The goal of this clinical research study is to learn if ruxolitinib or dasatinib in combination with chemotherapy can help to control Philadelphia Chromosome (Ph)-like acute lymphoblastic leukemia (ALL). The safety of these drug combinations will also be studied.

This is an investigational study. Ruxolitinib is FDA approved and commercially available for the treatment of myelofibrosis. Its use in this study is investigational. The study doctor can explain how ruxolitinib is designed to work. Dasatinib is FDA approved and commercially available for the treatment of CML and Philadelphia chromosome-positive ALL. All other drugs used in this study are FDA approved and commercially available. Their use together in this study is investigational. The study doctor can explain how the study drug(s) are designed to work.

You will be given standard drugs to help decrease the risk of side effects. You may ask the study staff for information about how the drugs are given and their risks.

Up to 92 participants will take part in this study. All will be enrolled at MD Anderson Cancer Center.


Condition or disease Intervention/treatment Phase
Leukemia Drug: Ruxolitinib Drug: Dasatinib Drug: Rituximab Drug: G-CSF Drug: Pegfilgrastim Drug: Methotrexate Drug: Cytarabine Drug: Cyclophosphamide Drug: Mesna Drug: Doxorubicin Drug: Vincristine Drug: Dexamethasone Drug: Solumedrol Drug: 6-mercaptopurine Drug: Prednisone Drug: Leucovorin Phase 2

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Detailed Description:

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to 1 of 2 study groups, based on the molecular type of the disease. You and the study staff will know which study drug you will receive:

  • Participants in Group A will receive ruxolitinib.
  • Participants in Group B will receive dasatinib.

Study Drug Administration:

Each study cycle is 21 days.

Participants in Group A will take ruxolitinib tablets by mouth 2 times a day (about 12 hours apart), with or without food.

Participants in Group B will take dasatinib tablets by mouth 1 time each day, with or without food. You should take the study drug at the same time each day.

If your doctor thinks it is needed, you may receive steroids and/or hydroxyurea if your white blood cell counts are too high.

If the disease responds to treatment with either ruxolitinib or dasatinib alone, you will continue to receive that drug by itself. That first cycle of therapy will be called Cycle 0. Your next cycle of dasatinib or ruxolitinib alone will continue to be called Cycle 0. Once you move to intensive chemotherapy (described below), that first cycle will be called Cycle 1.

If the disease does not respond to treatment by the end of the first cycle with ruxolitinib or dasatinib, you will also receive up to 2½ years of chemotherapy treatment. You will receive 8 cycles of intensive chemotherapy, using 2 different chemotherapy schedules. Once you complete intensive chemotherapy, you will receive up to 2 years of maintenance chemotherapy.

During intensive chemotherapy and maintenance chemotherapy, you may continue taking ruxolitinib or dasatinib every day, for as long as you are receiving benefit and you are not having intolerable side effects.

Chemotherapy is given several different ways:

  • By mouth
  • By vein, through a central venous catheter (CVC): A CVC is a sterile flexible tube that will be placed into a large vein while you are under local anesthesia. Your doctor will explain this procedure to you in more detail, and you will be required to sign a separate consent form for this procedure.
  • Intrathecal administration, through a lumbar puncture (spinal tap): A spinal tap (also called a lumbar puncture) is when fluid surrounding the spinal cord is removed by inserting a needle into the lower back. The affected area is numbed with local anesthetic during the procedure. It can also be used to give chemotherapy. The number of doses you receive will depend on how many doses the study doctor thinks is needed. Occasionally, a sample of the fluid obtained from the spinal taps may be tested for leukemia.

Your chemotherapy doses may be raised or lowered, depending on side effects. You will receive other drugs during chemotherapy to help prevent or lower the risk of certain side effects, including tumor lysis syndrome (breakdown products of the cancer cells entering the blood stream, which may cause possible weakness, low blood pressure, muscle cramps, kidney damage, and/or other organ damage).

Intensive Chemotherapy:

You will receive several drugs (listed below) as part of your chemotherapy. Each cycle of intensive chemotherapy is 21 days.

You may receive up to 8 cycles of intensive chemotherapy in the hospital. You will need to stay in the hospital for the first 4-5 days of each cycle.

Hyper-CVAD: Cycles 1, 3, 5, and 7:

  • On Days 1-3 of these cycles, you will receive cyclophosphamide by vein over about 3 hours, 2 times a day (about every 12 hours).
  • On Days 1-3 of these cycles, starting about 1 hour before your cyclophosphamide infusion, you will receive MESNA by vein over about 16 hours. MESNA is given to lower the risk of side effects.
  • On Day 4 of these cycles, you will receive doxorubicin by vein over 24-48 hours. On Days 4 and 11 (+/- 2 days) of these cycles, you will receive vincristine by vein over about 30 minutes.
  • On Days 1-4 and 11-14 (+/- 2 days) of these cycles, you will take dexamethasone by mouth 1 time a day or by vein over 30 minutes.
  • If the doctor thinks it is needed, on Days 1 and 11 of Cycles 1 and 3 only, you may also receive rituximab by vein over several hours.

Methotrexate alternating with cytarabine by vein: Cycles 2, 4, 6, and 8:

  • On Day 1 of these cycles, you will receive methotrexate by vein over about 24 hours (+/- 3 hours).
  • On Days 2-5 of these cycles, you will receive leucovorin by vein over or by mouth every 6 hours, beginning about 12 hours (+/- 2 hours) after you finish receiving methotrexate. Each infusion will last about 1 hour. Leucovorin is given to lower the risk of side effects such as mouth sores and kidney damage.
  • On Days 1-3 of these cycles, you will receive Solu-Medrol (methylprednisolone) by vein about every 12 hours. Each infusion will last about 2 hours.
  • On Days 2 and 3 of these cycles, you will receive cytarabine by vein about every 12 hours. Each infusion will last about 2 hours.
  • If the doctor thinks it is needed, on Days 1 and 8 for Cycles 2 and 4 only, you may also receive rituximab by vein over several hours.

Additional Treatment during Intensive Chemotherapy:

  • If your doctor thinks it is needed, on Day 2 of Cycles 1, 2, 3, and 4 only (+/- 2 days), you will receive intrathecal methotrexate to help lower the risk of the disease coming back in the fluid surrounding your brain.
  • If your doctor thinks it is needed, on Day 7 of Cycles 1, 2, 3, and 4 only (+/- 2 days), you will receive intrathecal cytarabine to help lower the risk of the disease coming back in the fluid surrounding your brain.
  • You will also receive either filgrastim every day or pegfilgrastim once after each cycle. The drug will be given as injection just under your skin, until your white blood cell counts have recovered. Your study doctor will tell you when this happens.

As long as the disease is responding to therapy and you have not had any intolerable side effects, you will continue on intensive chemotherapy for up to 8 courses. At that point, you will go on to the maintenance therapy phase.

Maintenance Chemotherapy:

Each maintenance cycle will be 28 days.

Maintenance chemotherapy will last for up to 2 years after you complete all 8 courses of intensive chemotherapy. During maintenance chemotherapy:

  • You will take mercaptopurine tablets by mouth 3 times a day.
  • You will take methotrexate tablets by mouth once a week.
  • On Day 1 of each cycle, you will receive vincristine by vein over about 30 minutes.
  • On Days 1-5 of each cycle, you will take prednisone by mouth.

Study Visits:

On Day 1 of Cycle 0:

  • You will have a physical exam.
  • Blood (about 1 tablespoon) will be drawn for routine tests. For the Day 1 tests, if you have had any of these tests or procedures in the last 3 days, they may not need to be repeated.

On Days 8 and 15 of Cycle 0, you will have a physical exam.

Every week during Cycle 0, blood (about 1 tablespoon each time) will be drawn for routine tests 3 times a week.

On Day 21 of every cycle, you will have a bone marrow aspiration and/or biopsy, to check the status of the disease. Once your doctor believes the disease has shown enough response, this will be done every 2-3 cycles at that point.

On Day 1 of Cycle 0 and every cycle after that, you will have a physical exam.

During the Intensive Chemotherapy cycles, blood (about 1 tablespoon each time) will be drawn for routine tests every week. During Maintenance Chemotherapy cycles, these routine blood samples will be drawn 1 time every month.

On Day 1 of every even-numbered cycle (Cycles 2, 4, 6, and so on), you will have an x-ray of your chest.

Length of Treatment:

You may receive the intensive chemotherapy for up to 8 cycles (up to 8 months) and then maintenance therapy for up to 2 years. You may continue to take ruxolitinib or dasatinib every day for as long as the doctor thinks it is in your best interest. You will no longer be able to take 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 the follow-up visit.

Follow-up:

You will have a follow-up visit 30 days after your last dose of the study drugs. At this visit, you will be asked about any side effects you may be having. If you cannot make it to the clinic for this visit, it can be done over the phone with a member of the study staff. The phone call should last about 10 minutes.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of the Combination of Ruxolitinib or Dasatinib With Chemotherapy in Patients With Philadelphia Chromosome (Ph)-Like Acute Lymphoblastic Leukemia (ALL)
Actual Study Start Date : July 2015
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023


Arm Intervention/treatment
Experimental: Ruxolitinib + Chemotherapy
Based on the molecular profile, participants stratified into 2 cohorts. For patients who fail to respond to a single agent ruxolitinib by 3 weeks (earlier if evidence of progressive disease), Hyper-CVAD chemotherapy added. Single-agent ruxolitinib cycle is cycle 0. Hyper-CVAD intensive cycles labelled cycles 1-8. The hyper-CVAD regimen consists of an intensive phase comprised of 8 cycles of chemotherapy alternating courses of hyper-CVAD (fractionated cyclophosphamide, vincristine, doxorubicin, dexamethasone) with courses of high-dose methotrexate and cytarabine every 21 days. Maintenance phase chemotherapy with POMP (6-mercaptopurine, vincristine, methotrexate, and prednisone) commences after the completion of the intensive phase of chemotherapy. Ruxolitinib given continuously concurrently with the intensive and maintenance phases.
Drug: Ruxolitinib
Starting dose of Ruxolitinib: 15 mg by mouth twice daily.
Other Names:
  • Jakafi
  • INCB018424
  • INC424

Drug: Rituximab
375 mg/m2 days 1 and 11 for cycles 1 and 3, and days 1 and 8 for cycles 2 and 4.
Other Name: Rituxan

Drug: G-CSF
5 mcg/kg/day within 72 ± 48 hours after completion of chemotherapy until neutrophil recovery 1 x 109/L or higher for Hyper-CVAD chemotherapy all courses.
Other Names:
  • Filgrastim
  • Neupogen

Drug: Pegfilgrastim
6 mg subcutaneously for one dose approximately 24 hours after completion of the chemotherapy may be substituted for G-CSF at the discretion of the treating physician for Hyper-CVAD chemotherapy all courses.
Other Names:
  • Neulasta
  • PEG-G-CSF

Drug: Methotrexate

12 mg (6 mg via Ommaya reservoir) day 2 of each of the first 4 cycles of Hyper-CVAD chemotherapy.

200 mg/m2 by vein over 2 hours followed by 800 mg/m2 by vein over 22 hours day 1 of Hyper-CVAD chemotherapy Courses 2, 4, 6, 8.

20 mg/m2 by mouth weekly for maintenance phase chemotherapy (POMP maintenance). Treatment cycle is 28 days.


Drug: Cytarabine

100 mg day 7 of each of the first 4 cycles of Hyper-CVAD chemotherapy during cycles 1 and 3 of Hyper-CVAD Courses 1, 3, 5, 7.

3 gm/m2 by vein over 2 hours every 12 hours for 4 doses on days 2, 3 for Hyper-CVAD Courses 2, 4, 6, 8.

Other Names:
  • Ara-C
  • Cytosar
  • DepoCyt
  • Cytosine arabinosine hydrochloride

Drug: Cyclophosphamide
300 mg/m2 by vein over 3 hours every 12 hours for 6 doses days 1, 2, 3 (total dose 1800 mg/m2) for Hyper-CVAD (Courses 1, 3, 5, 7).
Other Names:
  • Cytoxan
  • Neosar

Drug: Mesna
600 mg/m2/d by vein continuous infusion daily for 24 hours days 1 - 3 for Hyper-CVAD (Courses 1, 3, 5, 7).
Other Name: Mesnex

Drug: Doxorubicin
50 mg/m2 by vein over 24 hours on day 4, after last dose of Cyclophosphamide given for Hyper-CVAD (Courses 1, 3, 5, 7).
Other Names:
  • Doxorubicin hydrochloride
  • Adriamycin PFS
  • Adriamycin RDF
  • Adriamycin
  • Rubex

Drug: Vincristine

2 mg by vein on day 4 and day 11 for Hyper-CVAD (Courses 1, 3, 5, 7).

2 mg by vein approximately every 28 days for maintenance phase chemotherapy (POMP maintenance).


Drug: Dexamethasone
40 mg by vein or mouth daily days 1 - 4 and days 11 - 14 for Hyper-CVAD (Courses 1, 3, 5, 7).
Other Name: Decadron

Drug: Solumedrol
50 mg by vein over 2 hours approximately every 12 hours for 6 doses days 1 - 3 for Hyper-CVAD chemotherapy Courses 2, 4, 6, 8.
Other Names:
  • Methylprednisolone
  • Depo-Medrol
  • Medrol
  • Solu-Medrol

Drug: 6-mercaptopurine
50 mg tablets by mouth 3 times daily for maintenance phase chemotherapy (POMP maintenance). Treatment cycle is 28 days.
Other Names:
  • Mercaptopurine
  • 6-MP
  • Purinethol

Drug: Prednisone
200 mg by mouth daily days 1 to 5 approximately every 28 days, starting with vincristine (if given) for maintenance phase chemotherapy (POMP maintenance).

Experimental: Dasatinib + Chemotherapy
Based on the molecular profile, participants stratified into 2 cohorts. For patients who fail to respond to a single agent dasatinib by 3 weeks (earlier if evidence of progressive disease), Hyper-CVAD chemotherapy added. Single-agent dasatinib cycle is cycle 0. Hyper-CVAD intensive cycles labelled cycles 1-8. The hyper-CVAD regimen consists of an intensive phase comprised of 8 cycles of chemotherapy alternating courses of hyper-CVAD (fractionated cyclophosphamide, vincristine, doxorubicin, dexamethasone) with courses of high-dose methotrexate and cytarabine every 21 days. Maintenance phase chemotherapy with POMP (6-mercaptopurine, vincristine, methotrexate, and prednisone) commences after the completion of the intensive phase of chemotherapy. Dasatinib given continuously concurrently with the intensive and maintenance phases.
Drug: Dasatinib
Starting dose of Dasatinib: 100 mg by mouth once daily.
Other Names:
  • BMS-354825
  • Sprycel

Drug: Rituximab
375 mg/m2 days 1 and 11 for cycles 1 and 3, and days 1 and 8 for cycles 2 and 4.
Other Name: Rituxan

Drug: G-CSF
5 mcg/kg/day within 72 ± 48 hours after completion of chemotherapy until neutrophil recovery 1 x 109/L or higher for Hyper-CVAD chemotherapy all courses.
Other Names:
  • Filgrastim
  • Neupogen

Drug: Pegfilgrastim
6 mg subcutaneously for one dose approximately 24 hours after completion of the chemotherapy may be substituted for G-CSF at the discretion of the treating physician for Hyper-CVAD chemotherapy all courses.
Other Names:
  • Neulasta
  • PEG-G-CSF

Drug: Methotrexate

12 mg (6 mg via Ommaya reservoir) day 2 of each of the first 4 cycles of Hyper-CVAD chemotherapy.

200 mg/m2 by vein over 2 hours followed by 800 mg/m2 by vein over 22 hours day 1 of Hyper-CVAD chemotherapy Courses 2, 4, 6, 8.

20 mg/m2 by mouth weekly for maintenance phase chemotherapy (POMP maintenance). Treatment cycle is 28 days.


Drug: Cytarabine

100 mg day 7 of each of the first 4 cycles of Hyper-CVAD chemotherapy during cycles 1 and 3 of Hyper-CVAD Courses 1, 3, 5, 7.

3 gm/m2 by vein over 2 hours every 12 hours for 4 doses on days 2, 3 for Hyper-CVAD Courses 2, 4, 6, 8.

Other Names:
  • Ara-C
  • Cytosar
  • DepoCyt
  • Cytosine arabinosine hydrochloride

Drug: Cyclophosphamide
300 mg/m2 by vein over 3 hours every 12 hours for 6 doses days 1, 2, 3 (total dose 1800 mg/m2) for Hyper-CVAD (Courses 1, 3, 5, 7).
Other Names:
  • Cytoxan
  • Neosar

Drug: Mesna
600 mg/m2/d by vein continuous infusion daily for 24 hours days 1 - 3 for Hyper-CVAD (Courses 1, 3, 5, 7).
Other Name: Mesnex

Drug: Doxorubicin
50 mg/m2 by vein over 24 hours on day 4, after last dose of Cyclophosphamide given for Hyper-CVAD (Courses 1, 3, 5, 7).
Other Names:
  • Doxorubicin hydrochloride
  • Adriamycin PFS
  • Adriamycin RDF
  • Adriamycin
  • Rubex

Drug: Vincristine

2 mg by vein on day 4 and day 11 for Hyper-CVAD (Courses 1, 3, 5, 7).

2 mg by vein approximately every 28 days for maintenance phase chemotherapy (POMP maintenance).


Drug: Dexamethasone
40 mg by vein or mouth daily days 1 - 4 and days 11 - 14 for Hyper-CVAD (Courses 1, 3, 5, 7).
Other Name: Decadron

Drug: Solumedrol
50 mg by vein over 2 hours approximately every 12 hours for 6 doses days 1 - 3 for Hyper-CVAD chemotherapy Courses 2, 4, 6, 8.
Other Names:
  • Methylprednisolone
  • Depo-Medrol
  • Medrol
  • Solu-Medrol

Drug: 6-mercaptopurine
50 mg tablets by mouth 3 times daily for maintenance phase chemotherapy (POMP maintenance). Treatment cycle is 28 days.
Other Names:
  • Mercaptopurine
  • 6-MP
  • Purinethol

Drug: Prednisone
200 mg by mouth daily days 1 to 5 approximately every 28 days, starting with vincristine (if given) for maintenance phase chemotherapy (POMP maintenance).

Drug: Leucovorin
50 mg by vein followed by 15 mg by vein every 6 hours for 8 doses (or until MTX cleared) beginning 12 hours post MTX completion for courses 2, 4, 6, 8.
Other Names:
  • Citrovorum
  • Wellcovorin




Primary Outcome Measures :
  1. Response Rate (CR/CRi) of Ruxolitinib or Dasatinib in Combination With Philadelphia Chromosome (Ph)-Like Acute Lymphoblastic Leukemia (ALL) [ Time Frame: 42 days ]

    The Optimum two-stage design proposed by Simon implemented in each of the cohorts separately. For each cohort, a target CR/CRi of 25% assumed and a CR/CRi of 10% or lower considered as not desirable.

    Complete Response (CR): Disappearance of all clinical and/or radiologic evidence of disease, Neutrophil count ≥ 1.0 x 109/L, Platelet count ≥ 100 x 109/L, Normal bone marrow differential (≤ 5% blasts), No extra-medullary leukemia.

    Complete Remission without Incomplete Blood Count Recovery (CRi): CR except for ANC < 1.0 x 109/L and/or platelets < 100 x 109/L.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with previously treated B-cell ALL (relapsed and/or refractory after prior therapy)
  2. Bone marrow involvement with >/= 5% lymphoblasts
  3. Age >/= 10 years
  4. Documented genetic lesion(s) known to confer susceptibility to inhibition by either ruxolitinib or dasatinib or CRLF2 positivity by flow cytometry (for the Ruxolitinib cohort)
  5. Eastern Cooperative Oncology Group (ECOG) performance status </= 2
  6. Adequate organ function (total bilirubin < 2.0 mg/dL, SGPT or SGOT < 3 x upper limit of normal [ULN], creatinine < 2 mg/dL)
  7. Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (Beta-hCG) pregnancy test result within 14 days prior to the first dose of study drugs and must agree to use an effective contraception method during the study and for 30 days following the last dose of study drug. Females of non- childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy. Appropriate methods of birth control include the following: -- Any 2 of the following methods used together: --Birth control implants, injections, or pills (except for progesterone only pills), --Intrauterine device (IUD), --Vasectomy, --Tubal Ligation, --Barrier method (female or male condom with spermicide, cervical cap with spermicide, diaphragm with spermicide); --Male condom with spermicide and diaphragm; Male condom with spermicide and cervical cap
  8. (Continuation of #7) Unacceptable methods of birth control include using no birth control, withdrawal, rhythm method, vaginal sponge, any barrier method that does not use spermicide, progesterone only pills, and using male and female condoms at the same time.
  9. Males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 30 days following the last dose of study drug
  10. Patients or their legally authorized representative must provide written informed consent

Exclusion Criteria:

  1. Burkitt's Leukemia or Lymphoma, T-cell ALL or lymphoblastic lymphoma
  2. Patients having undergone prior allogeneic stem cell transplant within 3 months or having active graft versus host disease
  3. Patient is pregnant or breastfeeding
  4. Patients with uncontrolled active infections (Fever >/= 38 degree C, Septic shock)
  5. Isolated extramedullary relapse (i.e. testicular, central nervous system)
  6. Current or chronic hepatitis B or C infection, or known seropositivity for HIV
  7. Concurrent chemotherapy (except intrathecal chemotherapy)
  8. Major surgery within 4 weeks prior to first study dose
  9. Systemic chemotherapy/radiotherapy/investigational therapy within 14 days (with the exception of hydroxyurea and steroids) prior to starting therapy. For patients receiving ALL maintenance with 6-mercaptopurine, methotrexate, vincristine, and steroids - these agents should be discontinued at least 48 hours prior to start of study drugs. For patients on oral targeted therapies (such as imatinib, dasatinib, ponatinib), - these agents should be discontinued at least 48 hours prior to start of study drugs.
  10. Patients must have recovered from acute non hematologic toxicity (to </= grade 1) of all previous therapy prior to enrollment
  11. Known active central nervous system (CNS) leukemia, as defined by unequivocal morphologic evidence of lymphoblasts in the cerebrospinal fluid (CSF), use of CNS-directed local treatment for active disease within the prior 28 days, symptomatic CNS leukemia (i.e., cranial nerve palsies or other significant neurologic dysfunction) within 28 days. Patients may have history of CNS leukemic involvement if definitively treated with prior therapy and no evidence of active disease (defined as >/= 2 consecutive spinal fluid assessments with no evidence of disease) at the time of registration. Prophylactic intrathecal chemotherapy is not a criterion for exclusion.
  12. Patients with active heart disease (NYHA class 3-4 as assessed by history and physical examination, unstable angina/stroke/myocardial infarction within the last 6 months)
  13. Patients with a cardiac ejection fraction (as measured by either Multi-gated Acquisition (MUGA) scan or echocardiogram) < 40%. (Note: Patients who have had prior anthracycline exposure of >250 mg/m2 may be eligible after discussion with the PI).
  14. Second malignancy other than basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the cervix or the breast, unless they are successfully treated with curative intent for more than 2 years before entering the study
  15. Malabsorption syndrome or other conditions that preclude enteral route of administration
  16. Patients requiring strong CYP3A4 inhibitors. (Complete list of inhibitors can be found at: http://medicine.iupui.edu/clinpharm/ddis/table.aspx)
  17. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and/or would make the patient inappropriate for enrollment into this 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): NCT02420717


Contacts
Contact: Nitin Jain, MBBS 713-745-6080

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Incyte Corporation
Investigators
Principal Investigator: Nitin Jain, MBBS M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02420717     History of Changes
Other Study ID Numbers: 2014-0521
NCI-2015-00779 ( Registry Identifier: NCI CTRP )
First Posted: April 20, 2015    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Leukemia
Acute Lymphoblastic Leukemia
ALL
Philadelphia Chromosome (Ph)-Like
Relapsed
Refractory
6-mercaptopurine
Mercaptopurine
6-MP
Purinethol
Ruxolitinib
Jakafi
INCB018424
INC424
Dasatinib
BMS-354825
Sprycel
Rituximab
Rituxan
G-CSF
Filgrastim
Neupogen
Pegfilgrastim
Neulasta
PEG-G-CSF
Methotrexate
Cytarabine
Ara-C
Cytosar
DepoCyt

Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Philadelphia Chromosome
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Translocation, Genetic
Chromosome Aberrations
Pathologic Processes
Dexamethasone acetate
Prednisolone acetate
Methylprednisolone acetate
Dexamethasone
Prednisone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Liposomal doxorubicin
Cyclophosphamide
Rituximab
Doxorubicin
Methotrexate
Cytarabine
Vincristine