Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Chronic Lymphocytic Leukemia, Hodgkin's Lymphoma, Multiple Myeloma, Non-Hodgkin's Lymphoma
Conditions
Keywords
Leukemia, Lymphoma, Myeloma, Hematology, 852A, IRM, Oncology
Brief summary
The purpose of this study is to evaluate the anti-tumor activity of 852A when used to treat certain hematologic malignancies not responding to standard treatment.
Detailed description
852A will be administered as a subcutaneous injection (SC) 2 times per week for 12 weeks (24 doses) with provisions for dose escalation or reduction based on tolerability
Interventions
DRUG852A
Subcutaneous injection 0.6 mg/m2 2 times/week/12 weeks, may increase by 0.2 mg/m2 up to 1.2 mg/m2.
Sponsors
Pfizer
Masonic Cancer Center, University of Minnesota
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Subjects are eligible for the study if they meet all of the following Inclusion Criteria: * Diagnosis of one of the following hematologic malignancies not responding to at least 2 standard treatment regimens. Any criteria for persistent or recurrent disease acceptable, i.e. ≥5% blasts for acute leukemia. * acute lymphoblastic leukemia (ALL) * acute myeloid leukemia (AML) * non-Hodgkin's lymphoma (NHL) * Hodgkin's lymphoma (HL) * multiple myeloma (MM) * chronic lymphocytic leukemia (CLL) * Performance status - Karnofsky \> 50% for patients \> 10 years of age or Lansky \>50% for patients \< 10 year of age * Normal organ function within 14 days of study entry * If female and of childbearing potential, are willing to use adequate contraception (hormonal, barrier method, abstinence) prior to study entry and for the duration of study participation. A female is considered to be of childbearing potential unless she has had her uterus removed, had a double oophorectomy, or has been amenorrheic for at least 6 months after chemotherapy
Exclusion criteria
* Had/have the following prior/concurrent therapy: * Systemic corticosteroids (oral or injectable) within 7 days of first dose of 852A (topical or inhaled steroids are allowed) * Investigational drugs/agents within 14 days of first dose of 852A * Immunosuppressive therapy, including cytotoxic agents within 14 days of first dose of 852A (nitrosoureas within 30 days of first dose) * Drugs known to induce QT interval prolongation and/or induce Torsades De Pointes unless best available drug required to treat life-threatening conditions * Radiotherapy within 4 weeks of the first dose of 852A * Hematopoietic cell transplantation 4 weeks of first dose of 852A * Active infection or fever \> 38.5°C within 3 days of first dose of 852A * Cardiac ischemia, cardiac arrhythmias or congestive heart failure uncontrolled by medication * History of, or clinical evidence of, a condition which, in the opinion of the investigator, could confound the results of the study or put the subject at undue risk * Uncontrolled intercurrent or chronic illness * Active autoimmune disease requiring immunosuppressive therapy within 30 days * Active hepatitis B or C with evidence of ongoing viral replication * Hyperthyroidism * Uncontrolled seizure disorder * Active coagulation disorder not controlled with medication * Pregnant or lactating * Concurrent malignancy (if in remission, at least 5 years disease free) except for localized (in-situ) disease, basal carcinomas and cutaneous squamous cell carcinomas adequately treated * Proven active central nervous system (CNS) disease * Human Immunodeficiency Virus (HIV) positive * Congenital long QT syndrome or abnormal baseline QTc interval (\> 450 msec in males and \> 470 msec in females) after Bazett's correction (QTc msec = QT msec / square root of the RR interval in seconds) on screening electrocardiogram (ECG).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With 852A Response Using Modified Response Evaluation Criteria in Solid Tumors | Up to Week 12 | Stable disease in Non-Hogkin's Lymphoma = disease that does not satisfy complete (complete regression), partial (\> or = 50% reduction) or progressive disease (increase of 25%) by at least a 4-week period. Since Acute Myelogenous Leukemia is not a solid tumor, Complete Response (CR) = \<5% blasts with hematopoietic recovery (absolute neutrophil count \>500) at 4 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Who Received Steroids | Up to Week 12 | Number of patients who received steroids allowing successful continuation of therapy. |
| Measure of Immune Activation With Correlative Laboratory Studies | Up to Week 12 | — |
| Peak Concentrations of 852A | Up to Week 12 | Measurement of peak concentrations of 852A to correlate the side effects of tolerability in patients. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 852A Treatment Patients receiving at least 12 doses of 852A. | 6 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not receive all 24 doses of 852A | 6 |
Baseline characteristics
| Characteristic | 852A Treatment |
|---|---|
| Age, Categorical <=18 years | 2 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Age, Continuous | 39.8 years STANDARD_DEVIATION 23.32 |
| Region of Enrollment United States | 6 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 4 / 6 |
| serious Total, serious adverse events | 4 / 6 |
Outcome results
Primary
Number of Patients With 852A Response Using Modified Response Evaluation Criteria in Solid Tumors
Stable disease in Non-Hogkin's Lymphoma = disease that does not satisfy complete (complete regression), partial (\> or = 50% reduction) or progressive disease (increase of 25%) by at least a 4-week period. Since Acute Myelogenous Leukemia is not a solid tumor, Complete Response (CR) = \<5% blasts with hematopoietic recovery (absolute neutrophil count \>500) at 4 weeks.
Time frame: Up to Week 12
Population: Includes patients receiving at least 12 doses of 852A study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 852A Treatment | Number of Patients With 852A Response Using Modified Response Evaluation Criteria in Solid Tumors | Stable Disease | 1 Participants |
| 852A Treatment | Number of Patients With 852A Response Using Modified Response Evaluation Criteria in Solid Tumors | Partial Response | 1 Participants |
| 852A Treatment | Number of Patients With 852A Response Using Modified Response Evaluation Criteria in Solid Tumors | Progressive Disease | 4 Participants |
Secondary
Measure of Immune Activation With Correlative Laboratory Studies
Time frame: Up to Week 12
Population: Analysis not done to sale of agent - unable to perform.
Secondary
Number of Patients Who Received Steroids
Number of patients who received steroids allowing successful continuation of therapy.
Time frame: Up to Week 12
Population: Includes patients receiving at least 12 doses of 852A study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 852A Treatment | Number of Patients Who Received Steroids | 2 Participants |
Secondary
Peak Concentrations of 852A
Measurement of peak concentrations of 852A to correlate the side effects of tolerability in patients.
Time frame: Up to Week 12
Population: Not able to analysis due to sale of agent - unable to perform.