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CMC-544 in Relapsed Refractory Acute Lymphoblastic Leukemia (ALL)

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ClinicalTrials.gov Identifier: NCT01134575
Recruitment Status : Completed
First Posted : June 2, 2010
Last Update Posted : April 30, 2018
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this clinical research study is to learn if CMC-544 given alone, and possibly given in combination with rituximab, can help to control the disease in patients with ALL. The safety of the study drug(s) will also be studied.

Condition or disease Intervention/treatment Phase
Acute Lymphoblastic Leukemia Drug: CMC-544 (Inotuzumab Ozogamycin) Drug: Rituximab Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL) With CMC-544 (Inotuzumab Ozogamycin), With or Without Later Addition of Rituximab
Actual Study Start Date : June 4, 2010
Actual Primary Completion Date : April 18, 2018
Actual Study Completion Date : April 18, 2018


Arm Intervention/treatment
Experimental: CMC-544 (Inotuzumab Ozogamycin)
First patients > 16 years and < 16 years receive CMC-544 at a dose of 1.3 mg/m^2 by vein (IV) over 1 hour during Course 1, and 1.8 mg/m^2 IV over 1 hour during Course 2 and subsequently. In all other patients beginning dose of 1.8 mg/m^2 IV over 1 hour every 4 week cycle. With no improvement after 2 courses of CMC-544, addition of Rituximab dose 375 mg/m^2 IV (by vein) over 2-6 hours every 3-4 weeks.
Drug: CMC-544 (Inotuzumab Ozogamycin)
First patients > 16 years and < 16 years receive CMC-544 at a dose of 1.3 mg/m^2 by vein (IV) over 1 hour during Course 1, and 1.8 mg/m^2 IV over 1 hour during Course 2 and subsequently. In all other patients beginning dose of 1.8 mg/m^2 IV over 1 hour every 4 week cycle.

Drug: Rituximab
With no improvement after 2 courses of CMC-544, addition of Rituximab dose 375 mg/m^2 IV (by vein) over 2-6 hours every 3-4 weeks.
Other Name: rituxan




Primary Outcome Measures :
  1. Number of Patients with Response [ Time Frame: 4 week cycle ]
    Primary endpoint for efficacy is response which is defined as: Complete Remission (CR), Complete Remission without platelet recovery (CRp) or Partial Remission (PR).



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Previously treated ALL (including Burkitt's lymphoma and lymphoblastic lymphoma) in relapse or primary refractory. Patients in first relapse will be eligible regardless of the first remission duration. At least 10 patients in Salvage 1-2 will be treated to assess anti-ALL response more precisely.
  2. Age 16 years or older. Pediatric patients (<16 years old) will be allowed into the study after safety is established, that is at least 10 adult patients having received 1 or more cycles each.
  3. Zubrod performance status 0-3.
  4. Adequate liver function (bilirubin </= 1.5 mg/dL and SGPT or SGOT </= 3 x upper limit of normal [ULN], unless considered due to tumor), and renal function (creatinine </= 2 mg/dL). Even if organ function abnormalities are considered due to tumor, the upper limit for bilirubin is </= 2.0 mg/dL and creatinine </= 3 mg/dL.
  5. Male and female patients who are of childbearing potential agree to use an effective barrier method of birth control (e.g., latex condom, diaphragm, cervical cap, etc.) to avoid pregnancy. Female patients need a negative serum or urine pregnancy test within 14 days of study start (applies only if patient is of childbearing potential. Non-childbearing is defined as >/= 1 year postmenopausal or surgically sterilized).

Exclusion Criteria:

  1. Patient with active heart disease (NYHA class >/= 3 as assessed by history and physical examination).
  2. Patients with a cardiac ejection fraction (as measured by either MUGA or echocardiogram) < 45% are excluded.
  3. Patients who receive other chemotherapy. Patients must have been off previous therapy for >/= 2 weeks and must have recovered from acute toxicity (to grade 1 or less) of all previous therapy prior to enrollment (consent signing). (Concurrent therapy for central nervous system [CNS] prophylaxis or treatment for CNS relapse is permitted). Treatment may start earlier if necessitated by the patient's medical condition (e.g. rapidly progressive disease) following discussion with the Principal Investigator.
  4. Prior allogeneic stem cell transplant in previous 4 months.
  5. Peripheral lymphoblasts > 50 x 10^9/L.
  6. Pregnant and breast-feeding patients are excluded.
  7. Patients with known hepatitis B are excluded.

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): NCT01134575


Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Chair: Hagop Kantarjian, MD M.D. Anderson Cancer Center

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01134575     History of Changes
Other Study ID Numbers: 2009-0872
NCI-2011-01699 ( Registry Identifier: NCI CTRP )
First Posted: June 2, 2010    Key Record Dates
Last Update Posted: April 30, 2018
Last Verified: April 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:
Relapsed
Refractory
Acute Lymphoblastic Leukemia
ALL
Burkitt's lymphoma
Lymphoblastic lymphoma
CMC-544
Inotuzumab Ozogamycin
Rituxan
Rituximab

Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents