ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Blinatumomab in Patients With Pre B-cell ALL and B-cell NHL as Post-allo-HSCT Remission Maintenance

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: NCT03114865
Recruitment Status : Recruiting
First Posted : April 14, 2017
Last Update Posted : October 18, 2017
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary:
The investigators primary objective is to determine the safety and toxicity of incorporating blinatumomab into the post-allogeneic hematopoietic stem cell transplant (HSCT) maintenance setting for patients with CD19+-B-cell malignancies (Acute Lymphoblastic Leukemia [ALL], Non-Hodgkin's Lymphoma [NHL]).

Condition or disease Intervention/treatment Phase
Acute Lymphoblastic Leukemia B-cell Non Hodgkin Lymphoma Pre B-Cell Acute Lymphoblastic Leukaemia Drug: Blinatumomab Drug: Dexamethasone Early Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Blinatumomab in Patients With Pre B-cell Acute Lymphoblastic Leukemia (ALL) and B-cell Non-Hodgkin Lymphoma (NHL) as Post-allogeneic Stem Cell Transplant (Allo-HSCT) Remission Maintenance
Actual Study Start Date : September 5, 2017
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020


Arm Intervention/treatment
Experimental: Post-alloHSCT Maintenance
Blinatumomab will be administered as a continuous intravenous (IV) infusion over four weeks followed by a two-week treatment free interval. It is recommended that patients are hospitalized at least during the first three days of the first cycle and the first two days of the second cycles.
Drug: Blinatumomab
Cycle 1 - Days 1-7: 9 ug/day IV daily
Other Name: Blincyto

Drug: Blinatumomab
Cycle 1 - Days 8-28: 28 ug/day IV daily
Other Name: Blincyto

Drug: Blinatumomab
Cycle 2 - Days 1-28: 28 ug/day IV daily
Other Name: Blincyto

Drug: Dexamethasone
Day 1 of Cycle 1 and 2, prior to a step dose (such as cycle 1 day 8), or when restarting an infusion after an interruption of 4 hours or more: 20 mg IV




Primary Outcome Measures :
  1. Overall survival at two years post first treatment cycle [ Time Frame: 2 years ]
    Percentage of enrolled participants who receive BMT and Blinatumomab and are alive at two years post BMT.


Secondary Outcome Measures :
  1. Non-Relapse Mortality [ Time Frame: 2 years ]
    Percentage of participants who experience non-relapse mortality after 2 years.

  2. Progression-free survival [ Time Frame: 2 years ]
    Percentage of participants who experience progression-free survival after 2 years.

  3. Disease-free Survival [ Time Frame: 2 years ]
    Percentage of participants who experience disease-free survival after 2 years.

  4. Overall Survival [ Time Frame: 2 years ]
    Percentage of participants who experience overall survival after 2 years.

  5. Minimal Residual Disease [ Time Frame: 2 years ]
    Percentage of participants who convert from MRD to no MRD after treatment.



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

Inclusion Criteria:

  • Pre-B ALL, low and high grade NHL who underwent an alloHSCT using posttransplant CY GVHD prophylaxis (Pt-Cy alone or combination with MMF/tacrolimus or sirolimus) as follows:

    • Pre-B ALL patients in CR1 with high-risk features such as adverse cytogenetics including t(9;22), t(4;11) or other MLL rearrangements, t(8;14), complex karyotype (≥5 chromosomal abnormalities), hypodiploidy (<44 chromosomes), low hypodiploidy (30-39 chromosomes)/near triploidy (60-68 chromosomes), high WBC count at presentation (≥30,000), lack of achievement of complete remission after standard induction chemotherapy (but achieved CR1 following salvage or consolidation), or persistence of detectable disease after induction and consolidation (intensification) or pre-transplant as documented on any of routine clinical tests (morphology, flow cytometry, cytogenetics or molecular studies) OR all Pre-B ALL patients in second and higher CR
    • Low and high grade NHL following a nonmyeloablative (reduced-intensity conditioning) transplant irrespective of pre-transplant disease status
  • Patients should be at least 60 but not more than 180 days from transplant with documented count recovery (ANC >1 x109/L, and non-transfused platelets >30x109/L) and no evidence of disease progression
  • ECOG performance status 0-2
  • Ability to give informed consent
  • In agreement to use an effective barrier method of birth control (hormonal or barrier method of birth control; abstinence) to avoid pregnancy during the study and for a minimum of 30 days after study treatment, for all male and female patients who are fertile
  • Age ≥18 years
  • Patients may have received any number of prior regimens to achieve remission. Patients previously treated with blinatumomab will be eligible as long as they did not experience unacceptable toxicities with prior blinatumomab administration. If patient was refractory (no response) to blinatumomab in the past, patient will be eligible if there was no evidence of CD19 loss on leukemia cells.

Exclusion Criteria:

  • Lack of engraftment (less than 85% donor DNA in bone marrow or peripheral blood after allogeneic HSCT).
  • Active or untreated disease in central nervous system or testes
  • Patient has received chemotherapy or radiotherapy (with the exception of intrathecal chemotherapy) within 2 weeks of starting blinatumomab. Patient could receive intrathecal prophylactic chemotherapy within a week prior to starting blinatumomab.
  • Patients with active uncontrolled infection or uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Patients with active acute GVHD (grade 2-4) and active moderate or severe chronic GVHD with GVHD therapy initiation or escalation within 28 days. Patients who required steroids for the treatment of GVHD will need to be off steroids for at least 2 weeks before enrollment. (Topical steroids or physiologic adrenal replacement steroid doses are allowed).
  • Patients requiring calcineurin inhibitors (i.e. tacrolimus or sirolimus) or other systemic immunosuppressants (cyclosporine (CNI); methotrexate or similar) for GVHD prophylaxis or treatment within 2 weeks prior to study enrollment.
  • Inadequate end organ function defined as AST, ALT, and alkaline phosphatase > 3X ULN, bilirubin >=1.5X ULN, or creatinine >=2 mg/dL
  • Patients with Ph-positive ALL who are eligible for post-transplant TKI maintenance based on a demonstrated sensitivity to TKIs pre-transplant (patients with known intolerance or resistance to TKI will be eligible)
  • Evidence of progressive disease post-transplant
  • Women who are pregnant or lactating
  • Known hypersensitivity to blinatumomab
  • Patients with a concurrent active malignancy for which they are receiving treatment
  • Concurrent use of any other investigational drugs
  • Patient who have a history or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, psychosis, or other significant CNS abnormalities. A history of treated CNS leukemia or lymphoma will be allowed if recent imaging and CSF studies confirm the absence of active CNS disease at the time of study entry
  • Weight <45 kg
  • Patients receiving other post-transplant maintenance therapies
  • Infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus or hepatitis C virus (HCV)

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): NCT03114865


Contacts
Contact: Ivana Gojo, MD 410-502-8775 igojo1@jhmi.edu

Locations
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21287
Contact: Ivana Gojo, MD    410-502-8775    igojo1@jhmi.edu   
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Investigators
Principal Investigator: Ivana Gojo, MD Johns Hopkins University

Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT03114865     History of Changes
Other Study ID Numbers: J1713
IRB00125679 ( Other Identifier: JHMIRB )
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: October 18, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
bone marrow
bone marrow transplant
allogeneic
tacrolimus
cyclophosphamide
Blinatumomab

Additional relevant MeSH terms:
Epstein-Barr Virus Infections
Lymphoma
Leukemia
Lymphoma, Non-Hodgkin
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Lymphoma, B-Cell
Burkitt Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Dexamethasone
Blinatumomab
Antibodies, Bispecific
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists