Safety Study to Assess AFM11 in Patients With Relapsed and/or Refractory CD19 Positive B-cell NHL

Description

 

The purpose of this study is to determine whether AFM11 is safe and active in the treatment of relapsed and/or refractory Non-Hodgkin Lymphoma (NHL) and Acute Lymphoblastic Leukemia (ALL).

Study Start Date

April 2014

Estimated Completion Date

November 2016

Interventions

  • Drug: AFM11

Specialties

  • Oncology: Leukemia/Lymphoma
  • Pharmacy: Chemotherapy/Oncology
  • Physician Assistant: Hematology/Oncology

MeSH Terms

  • Leukemia
  • Lymphoma, B-Cell

Study ID

Affimed Therapeutics AG -- AFM11-101

Status

Unknown

Trial ID

NCT02106091

Study Type

Interventional

Trial Phase

Phase 1

Enrollment Quota

50

Sponsor

Affimed Therapeutics AG

Inclusion Criteria (NHL patients):
  • Patients with CD19+, relapsed or refractory histologically (WHO classification) confirmed follicular lymphoma, marginal zone lymphoma, lymphoplasmocytic lymphoma, mantle cell lymphoma, diffuse large B-cell lymphoma, mediastinal B-cell lymphoma, or transformed B-cell lymphomas.
  • Patients with either indolent or aggressive NHL.
  • Patients who relapsed or were refractory to the approved standard therapy, which must have included 1 treatment line with rituximab plus chemotherapy, and who are not candidates for bone marrow transplant with a curative intent.
  • Measurable disease (at least 1 lesion ? 1.5 cm) documented by CT scan.
  • Disease progression requiring therapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status ? 2. Exclusion Criteria (NHL patients):
  • Total number of B-cells (healthy and malignant combined) in the peripheral blood exceeds the upper physiological limit (as per institutional guidance) of total B-cell counts in healthy individuals.
  • Autologous Hematopoietic stem cell transplant (HSCT) within 3 months prior to start of AFM11 treatment.
  • Prior allogeneic HSCT.
  • Abnormal hematological laboratory values as defined below: 1. Peripheral lymphocyte count > 20 × 10^9/L 2. Platelet count ? 75,000/µL 3. Hemoglobin level ? 9 g/dL.
  • Known or suspected central nervous system (CNS) involvement. 1. History of or current relevant CNS pathology as epilepsy, seizure, paresis, aphasia, apoplexia, severe brain injuries, cerebellar disease, organic brain syndrome, psychosis. 2. Evidence for presence of malignant disease, inflammatory lesions, and/or vasculitis on cerebral MRI. 3. Infiltration of the cerebrospinal fluid by malignant B-cells, confirmed by lumbar puncture.
  • Cancer chemotherapy within 4 weeks prior to start of AFM11 treatment, or at least 4 times the respective half-lives, whichever is longer.
  • Radiotherapy within 4 weeks prior to start of AFM11 treatment.
  • Therapy with antibody, or antibody constructs within 4 weeks prior to start of AFM11 treatment, or at least 4 times the respective half-lives, whichever is longer.
  • Prior treatment with alemtuzumab (Campath®) within 3 months prior to start of AFM11 treatment.
  • Treatment with any investigational agent within 4 weeks prior to start of AFM11 treatment, or at least 4 times the respective half-life, whichever is longer.
  • Abnormal renal or hepatic function as follows: aspartate aminotransferase (AST or serum glutamic oxaloacetic transaminase [SGOT]) and/or alanine aminotransferase (ALT or serum glutamic pyruvic transaminase [SGPT]) ? 2.5 × upper limit of normal (ULN)
  • total bilirubin ? 1.5 × ULN serum creatinine ? 2 × ULN creatinine clearance < 50 mL/minute.
  • History of malignancy other than B-cell lymphoma or B-precursor ALL within 5 years prior to study entry, with the exception of basal cell carcinoma of the skin or carcinoma in situ of the cervix.
  • Uncontrolled infections
  • known bacteremia.
  • Regular dose of corticosteroids during the 4 weeks prior to start of AFM11 treatment of this study or anticipated need of corticosteroids exceeding prednisone 20 mg/day or equivalent, or any other immunosuppressive therapy within 4 weeks prior to start of AFM11 treatment.
  • Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B or hepatitis C virus.
  • Pregnant or nursing women or women of childbearing potential not willing to use an effective form of contraception during participation in the study and at least 3 months thereafter. Male patients not willing to ensure that during the study and at least 3 months thereafter no fathering takes place.
  • Patients with B-cell chronic lymphocytic leukemia, small lymphocytic lymphoma, and Waldenström's macroglobulinemia. Inclusion Criteria (ALL patients):
  • Patients with CD19+ B-precursor ALL relapsed after at least induction and consolidation or having refractory disease and who are not candidates for bone marrow transplant with a curative intent.
  • More than 5% blasts in bone marrow.
  • In patients with high tumor burden (e.g. more than 50% blasts, elevated lactate dehydrogenase [LDH]) greater than 2-fold ULN, or signs of extramedullar involvement), a pre-treatment with 10 mg/m² dexamethasone is required for up to 5 days.
  • Patients with Philadelphia positive ALL who failed or were intolerant to therapy with at least 2 approved tyrosine kinase inhibitors.
  • Eastern Cooperative Oncology Group performance status ? 2. Exclusion Criteria (ALL patients):
  • Autologous HSCT within 3 months prior to start of AFM11 treatment.
  • Active acute or chronic graft-versus-host disease. All graft-versus-host disease medication should be omitted for at least 4 weeks prior to start of AFM11 treatment.
  • Allogeneic HSCT within 3 months prior to start of AFM11 treatment.
  • No treatment with donor-lymphocyte infusions within 3 months of start of AFM11 treatment.
  • Abnormal hematological laboratory values as defined below: 1. Platelet count ? 20,000/µL 2. Hemoglobin level ? 9 g/dL.
  • Known or suspected CNS involvement. 1. History of or current relevant CNS pathology as epilepsy, seizure, paresis, aphasia, apoplexia, severe brain injuries, cerebellar disease, organic brain syndrome, psychosis. 2. Evidence for presence of malignant disease, inflammatory lesions, and/or vasculitis on cerebral MRI. 3. Infiltration of the cerebrospinal fluid by malignant B-cells, confirmed by lumbar puncture.
  • Cancer chemotherapy within 4 weeks prior to start of AFM11 treatment, or at least 4 times the respective half-lives, whichever is longer.
  • Radiotherapy within 4 weeks prior to start of AFM11 treatment.
  • Therapy with antibody, or antibody constructs within 4 weeks prior to start of AFM11 treatment, or at least 4 times the respective half-lives, whichever is longer.
  • Prior treatment with alemtuzumab (Campath®) within 3 months prior to start of AFM11 treatment.
  • Treatment with any investigational agent within 4 weeks prior to start of AFM11 treatment, or at least 4 times the respective half-life, whichever is longer.
  • Abnormal renal or hepatic function as follows: AST (or SGOT) and/or ALT (or SGPT) ? 2.5 × ULN
  • total bilirubin ? 1.5 × ULN serum creatinine ? 2 × ULN creatinine clearance < 50 mL/minute.
  • History of malignancy other than B-cell lymphoma or B-precursor ALL within 5 years prior to study entry, with the exception of basal cell carcinoma of the skin or carcinoma in situ of the cervix.
  • Uncontrolled infections
  • known bacteremia.
  • Regular dose of corticosteroids during the 4 weeks prior to start of AFM11 treatment of this study or anticipated need of corticosteroids exceeding prednisone 20 mg/day or equivalent, or any other immunosuppressive therapy within 4 weeks prior to study entry.
  • Known infection with HIV or chronic infection with hepatitis B or hepatitis C virus.
  • Pregnant or nursing women or women of childbearing potential not willing to use an effective form of contraception during participation in the study and at least 3 months thereafter. Male patients not willing to ensure that during the study and at least 3 months thereafter no fathering takes place.
  • Patients with B-cell chronic lymphocytic leukemia, small lymphocytic lymphoma, and Waldenström's macroglobulinemia.
  • Gender

    Both

    Ages

    18 Years and older

    Accepts Healthy Volunteers

    No

    Study Locations and Contact Information (1)

    Study Location Distance Name Phone Email
    Tufts Medical Center - Boston, Massachusetts 3.2 miles None None None

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