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Study of Moxetumomab Pasudotox in Patients With Relapsed and/or Refractory Acute Lymphoblastic Leukemia (ALL)

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ClinicalTrials.gov Identifier: NCT01891981
Recruitment Status : Terminated (Ph I Exempt as it did not proceed to the Phase II terminated early by the supporter)
First Posted : July 3, 2013
Last Update Posted : February 28, 2018
Sponsor:
Collaborator:
MedImmune LLC
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this clinical research study is to find the highest tolerable dose of moxetumomab pasudotox that can be given to patients with relapsed and/or refractory ALL.

Condition or disease Intervention/treatment Phase
Leukemia Drug: Moxetumomab Pasudotox Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Study of Moxetumomab Pasudotox in Patients With Relapsed and/or Refractory Acute Lymphoblastic Leukemia (ALL)
Actual Study Start Date : December 17, 2013
Actual Primary Completion Date : April 12, 2017
Actual Study Completion Date : April 12, 2017


Arm Intervention/treatment
Experimental: Moxetumomab Pasudotox

Phase I Starting Dose: 30 µg/kg by vein every other day for 6 doses on Days 1, 3, 5, 7, 9, and 11 of each 21-day cycle.

Phase II Starting Dose: Maximum tolerated dose from Phase I.

Drug: Moxetumomab Pasudotox

Phase I Starting Dose: 30 µg/kg by vein every other day for 6 doses on Days 1, 3, 5, 7, 9, and 11 of each 21-day cycle.

Phase II Starting Dose: Maximum tolerated dose from Phase I.





Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) of Moxetumomab [ Time Frame: After second 21 day cycle ]
    Maximum tolerated dose defined as the highest dose level in which 6 patients have been evaluated for toxicity and fewer than 2 dose limiting toxicities (DLTs) were observed. A non-hematologic DLT defined as a clinically significant Grade 3 or 4 adverse event or abnormal laboratory value assessed by treating physician as related to study drug (and unrelated to disease progression, intercurrent illness, or concomitant medications) occurring during the first 21(+/- 2) days on study. A hematologic dose-limiting toxicity defined as severe myelosuppression with a hypoplastic marrow with less than 5% cellularity and no evidence of leukemia 42 days from start of therapy.


Secondary Outcome Measures :
  1. Overall Response Rate [ Time Frame: After second 21 day cycle ]
    Primary efficacy outcome is overall response rate (including CR, CRi and PR). Complete remission (CR): Neutrophil count > 1.0 x109/L, platelet count >100x109/L, and normal marrow differential (< 5% blasts). Complete remission without recovery of counts (CRi): Peripheral blood and marrow results as for CR, but with incomplete recovery of counts (platelets < 100 x 109/L; neutrophils < 1 x 109/L). Partial remission (PR): Peripheral blood count recovery as for CR, but with decrease in marrow blasts of > 50% and not more than 25% abnormal cells in the marrow. Kaplan and Meier product limit method used to estimate the event-free survival (EFS) and overall survival (OS) and a 95% confidence interval for the median EFS and OS provided. Univariate and multivariate Cox proportional hazards regression model used to identify prognostic factors for EFS and OS.



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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. Patients age 18 years or older with previously treated ALL (relapsed and/or refractory after prior therapy); patients with relapsed/refractory biphenotypic leukemia expressing the appropriate antigen (CD22) are also eligible to participate, Pediatric patients younger than 18 may be considered with sponsor approval once the MTD has been established in the adult population.
  2. Eastern Cooperative Oncology Group (ECOG) Performance status 0-2.
  3. Adequate liver function (bilirubin less than or equal to 1.5 mg/dL and serum glutamate pyruvate transaminase (SGPT) or serum glutamate oxaloacetate transaminase (SGOT) less than or equal 2.5 x upper limit of normal (ULN), unless considered due to tumor or hemolysis), and renal function ( Calculated CrCl of greater than or equal to 50 or serum creatinine less than 2 x ULN.) Even if organ function abnormalities are considered due to tumor, the upper limit for bilirubin is less than or equal to 2.0 mg/dL (unless due to hemolysis or Gilbert's disease, i.e. mainly indirect bilirubin) and creatinine less than or equal 2 mg/dL
  4. Provision of written informed consent.

Exclusion Criteria:

  1. Patient with active heart disease (NYHA class greater than or equal to 2 as assessed by history and physical examination).
  2. Patients with a cardiac ejection fraction (as measured by either multigated radionuclide angiography (MUGA) or echocardiogram) less than 40%
  3. Patients with active hepatitis
  4. Pregnant or breast-feeding women. Women of childbearing potential must have a negative urine or serum pregnancy test within 14 days of start of treatment.
  5. prior radioimmunotherapy within 3 years of enrollment
  6. serum albumin less than 2g/dL
  7. oxygen saturation at rest by pulse oximetry less than 88% or PaO2 less than or equal to 55mm Hg
  8. history of microangiopathic hemolysis, TTP or HUS.
  9. symptomatic central nervous system (CNS) involvement
  10. Less than 100 days post -transplant or any evidence of active graft-versus-host disease (GVHD)
  11. systemic chemotherapy less than 14 days prior; however treatment may start earlier if there is evidence of rapidly progressive disease if approved by the Principal Investigator
  12. monoclonal antibody therapy less than 1 month
  13. investigational agents within 28 days of dosing; however treatment may start earlier if there is evidence of rapidly progressive disease if approved by the Principal Investigator
  14. HIV+/AIDS
  15. history of exposure to pseudomonas exotoxin containing molecule
  16. Patients with active lung infection or active pulmonary edema.
  17. Patients with laboratory findings consistent with Grade equal to greater than 3 disseminated intravascular coagulation (DIC) or any Grade 2 DIC that does not correct.
  18. Patients with clinically significant ophthalmologic findings (as determined by an ophthalmologist) during screening should be excluded from the trial
  19. Pre-treatment greater than corrected QT interval (QTc) interval of 490 ms

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): NCT01891981


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
MedImmune LLC
Investigators
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Principal Investigator: Farhad Ravandi-Kashani, MD M.D. Anderson Cancer Center

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01891981     History of Changes
Other Study ID Numbers: 2012-1143
NCI-2013-02207 ( Registry Identifier: NCI CTRP )
First Posted: July 3, 2013    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018

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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:
Leukemia
Acute Lymphoblastic Leukemia
ALL
Relapsed and/or refractory
Moxetumomab Pasudotox
Maximum tolerated dose
MTD
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
Immunotoxin HA22
Antineoplastic Agents