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Hyper-CVAD With Liposomal Vincristine in Acute Lymphoblastic Leukemia

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01319981
Recruitment Status : Active, not recruiting
First Posted : March 22, 2011
Last Update Posted : January 28, 2020
Sponsor:
Collaborator:
Spectrum Pharmaceuticals, Inc
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 intensive chemotherapy (hyper-CVAD therapy) given in combination with liposomal vincristine (Marqibo), in addition to rituximab for patients who are CD20 positive and/or imatinib, dasatinib, or ruxolitinib for patients with the Philadelphia (Ph) chromosome, can help to control ALL or lymphoblastic lymphoma. The safety of this treatment will also be studied. CD20 is a protein "marker" that is found in leukemia or lymphoma cells.

This is an investigational study. Liposomal vincristine is FDA approved for the treatment of patients with CLL who have relapsed at least 2 times. All of the other study drugs used in this study are FDA approved and commercially available. The combination of liposomal vincristine with the other study drugs is also being used in research only.

Up to 65 patients will take part in this study. All will be enrolled at MD Anderson.


Condition or disease Intervention/treatment Phase
Leukemia Drug: Rituximab Drug: Imatinib Drug: Cyclophosphamide Drug: Doxorubicin Drug: Mesna Drug: VSLI Drug: Solu-Medrol Drug: Methotrexate Drug: Ara-C Drug: G-CSF Drug: Pegfilgrastim Drug: Dexamethasone Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hyper-CVAD With Liposomal Vincristine (Hyper-CMAD) in Acute Lymphoblastic Leukemia
Actual Study Start Date : March 5, 2013
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Experimental: Hyper-CMAD + Rituximab
Odd Courses 1, 3, 5, 7: Rituximab 375 mg/m2 IV Day 1 & 8 Courses 1 & 3; Imatinib oral 600 mg days 1-14 Course 1 then continuously; Cyclophosphamide 300 mg/m2 IV every; 12 hours for 6 doses; Mesna 600 mg/m2/day IV Days 1-3; Doxorubicin 50 mg/m2 IV CVC Day 4; VSLI 2.25 mg/M2 IV Day 1 & 8; Pegfilgrastim 6 mg/kg after chemotherapy + G-CSF 10 µg/kg/day; Dexamethasone 40 mg IV or P.O. daily days 1-4 and days 11-14 +/- 3 days.
Drug: Rituximab
In CD20-positive patients, 375 mg/m2 by vein on day 1 and 8 for Courses 1 and 3; and day 1 and 8 of Courses 2 and 4.
Other Name: Rituxan

Drug: Imatinib
600 mg by mouth daily days 1-14 for course 1 and continuously on all other courses for patients who are Philadelphia chromosome positive (Ph+).
Other Names:
  • Imatinib Mesylate
  • Gleevec
  • ST1571
  • NSC-716051

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

Drug: Doxorubicin
50 mg/m2 by vein over 24 hours on day 4 after last dose of Cyclophosphamide for courses 1, 3, 5, 7
Other Names:
  • Adriamycin
  • Rubex

Drug: Mesna
600 mg/m2 by vein continuous infusion daily for 24 hours days 1-3 for courses 1, 3, 5, 7
Other Name: Mesnex

Drug: VSLI
2.0 mg/m2 by vein on day 1 and day 8 for courses 1, 3, 5, 7
Other Names:
  • Liposomal Vincristine
  • Vincristine Sulfate Liposomes Injection
  • Marqibo

Drug: G-CSF
10 µg/kg/day (rounded) given subcutaneously until neutrophil recovery to 1 x 10^9/L or higher can be substituted or can be added if neutrophils have not recovered to 1 x 10^9/L by day 21.
Other Names:
  • Filgrastim
  • Neupogen

Drug: Pegfilgrastim
6 mg/kg (rounded) within 72 hrs after completion of chemotherapy.
Other Name: Neulasta

Drug: Dexamethasone
40 mg by vein or by mouth daily days 1-4 and days 11-14 for courses 1, 3, 5, 7
Other Name: Decadron

Experimental: Hyper-CVAD
Courses 2, 4, 6, 8: Rituximab 375 mg/m2 IV Day 1 & 8 Courses 2 & 4; Imatinib oral 600 mg; Methotrexate 200 mg/m2 IV over 2 hours followed by 8-0- mg/m2 over 22 hours on Day 1; Solu-Medrol 40 mg IV hours approximately every 12 hours +/- 2 hours for 6 doses days 1-3 +/- 3 days; Decadron 40 mg IV or orally 4 times Days 1-4; Ara-C 3 gm/m2 IV every 2 hours, 4 doses on Days 2-3; Pegfilgrastim 6 mg/kg after chemotherapy + G-CSF 10 mg/kg/day.
Drug: Rituximab
In CD20-positive patients, 375 mg/m2 by vein on day 1 and 8 for Courses 1 and 3; and day 1 and 8 of Courses 2 and 4.
Other Name: Rituxan

Drug: Imatinib
600 mg by mouth daily days 1-14 for course 1 and continuously on all other courses for patients who are Philadelphia chromosome positive (Ph+).
Other Names:
  • Imatinib Mesylate
  • Gleevec
  • ST1571
  • NSC-716051

Drug: VSLI
2.0 mg/m2 by vein on day 1 and day 8 for courses 1, 3, 5, 7
Other Names:
  • Liposomal Vincristine
  • Vincristine Sulfate Liposomes Injection
  • Marqibo

Drug: Solu-Medrol
40 mg by vein every 12 hours for 6 doses days 1-3 for courses 2, 4, 6, 8.
Other Names:
  • Methylprednisolone
  • Depo-Medrol
  • Medrol

Drug: Methotrexate
200 mg/m2 IV over 2 hrs followed by 800 mg/m2 over 22 hrs on day 1 beginning after the completion of rituximab for Courses 2, 4, 6, and 8.

Drug: Ara-C
3 gm/m2 by vein over 2 hours every 12 hours for 4 doses on days 2, 3 for Courses 2, 4, 6, and 8.
Other Names:
  • Cytarabine
  • Cytosar
  • DepoCyt
  • Cytosine Arabinosine Hydrochloride

Drug: G-CSF
10 µg/kg/day (rounded) given subcutaneously until neutrophil recovery to 1 x 10^9/L or higher can be substituted or can be added if neutrophils have not recovered to 1 x 10^9/L by day 21.
Other Names:
  • Filgrastim
  • Neupogen

Drug: Pegfilgrastim
6 mg/kg (rounded) within 72 hrs after completion of chemotherapy.
Other Name: Neulasta




Primary Outcome Measures :
  1. Number of Patients With Complete Remission at One Year [ Time Frame: 1 year ]
    The complete remission (CR) rate at one year calculated as the total number of patients who are in CR at one year divided by the total number of patients who received at least one dose of HCVAD with liposomal vincristine.



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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Newly diagnosed previously untreated ALL or lymphoblastic lymphoma >/= 18 years old. Allow urgent administration of cytarabine/hydrea/atra prior to starting treatment on protocol. Allow previous administration of up to one course of Hyper-CVAD and/or FDA approved TKI.
  2. Zubrod performance status </= 3.
  3. Adequate liver function (bilirubin </= 3.0 mg/dl unless considered due to tumor) and renal function (creatinine </= 3.0 mg/dl, unless considered due to tumor).
  4. No active co-existing malignancy with life expectancy less than 12 months due to that malignancy.
  5. All men and women of childbearing potential who are participating in the study must agree to use effective forms of birth control throughout the duration of their treatment.
  6. Adequate cardiac function as assessed clinically

Exclusion Criteria:

  1. Pregnant or lactating women. Women of childbearing potential (WOCB) must have a blood or urine pregnancy test within 7 days prior to administration of the study drug. (WOCB is defined as a woman who has not undergone hysterectomy or bilateral oophorectomy and has not been naturally postmenopausal for at least 24 consecutive months).
  2. Active Grade III-IV cardiac failure as defined by the New York Heart Association criteria, uncontrolled angina or MI within 6 months.
  3. Patients with medical conditions that compromise their ability to complete the study or confound interpretation of study results.

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): NCT01319981


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Spectrum Pharmaceuticals, Inc
Investigators
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Principal Investigator: Elias Jabbour, MD M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01319981    
Other Study ID Numbers: 2008-0598
NCI-2011-00861 ( Registry Identifier: NCI CTRP )
First Posted: March 22, 2011    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020

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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:
Acute Lymphoblastic Leukemia
ALL
Lymphoblastic lymphoma
Cytoxan
Neosar
Mesnex
Liposomal Vincristine
Vincristine Sulfate Liposomes Injection
Marqibo
Dexamethasone
Adriamycin
Rubex
Cytarabine
Cytosar
DepoCyt
Cytosine Arabinosine Hydrochloride
Imatinib Mesylate
Gleevec
ST1571
NSC-716051
Filgrastim
Neupogen
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cytarabine
Dexamethasone
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Cyclophosphamide
Rituximab
Doxorubicin
Methotrexate
Vincristine
Imatinib Mesylate
Prednisolone hemisuccinate
Prednisolone phosphate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents