Relapsed Acute Myelogenous Leukemia Clinical Trial
Official title:
T2007-002 A Phase II Study of Clofarabine With Etoposide and Cyclophosphamide in Relapsed/Refractory AML (IND 104,650)
| Verified date | February 2020 |
| Source | Therapeutic Advances in Childhood Leukemia Consortium |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Clofarabine is a drug approved by the FDA (Food and Drug Administration) for treating children (age 1-21) with leukemia. This research study will use clofarabine with two other cancer fighting drugs. Clofarabine will be used together with etoposide (VePesid®, VP-16) and cyclophosphamide (Cytoxan®).
| Status | Terminated |
| Enrollment | 6 |
| Est. completion date | July 15, 2011 |
| Est. primary completion date | July 15, 2011 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 1 Year to 21 Years |
| Eligibility |
Inclusion Criteria: - Age: patients must be = 1 and = 21 years of age at the of study entry. - Diagnosis: - Patients must have a diagnosis of first or second relapse or refractory acute myelogenous leukemia (AML) according to WHO classification with = 5% blasts in the bone marrow, with or without extramedullary disease. - Patients may have CNS 1 or CNS 2 disease but not CNS 3. - Performance Level: Karnofsky > 50% for patients > 16 years of age and Lansky > 50% for patients = 16 years of age. - Prior Therapy: - Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study. - Patient has not received more than 2 previous induction attempts. (Frontline therapy is included in this count). - Patients must have adequate venous access. - At least 1 year must have elapsed since hematopoietic stem cell transplant (HSCT) and patients must not have active GVHD. - Reproductive Function - Female patients of childbearing potential must have a negative serum pregnancy test confirmed within 2 weeks prior to enrollment. - Female patients with infants must agree not to breastfeed their infants while on this study. - Male and female patients of child-bearing potential must agree to use an effective method of contraception approved by the investigator during the study and for a minimum of 6 months after study treatment. - Renal and Hepatic Function: Patient must have adequate renal and hepatic functions as indicated by the following laboratory values: - Patients must have a normal calculated creatinine clearance. - Pediatric Population (age <18): Calculated creatinine clearance = 90 ml/min/1.73m2 as calculated by the Schwartz formula for estimated glomerular filtration rate (GFR) where GFR (ml/min/1.73 m2) = k*Height (cm)/serum creatinine (mg/dl). k is a proportionality constant which varies with age and is a function of urinary creatinine excretion per unit of body size; 0.45 up to 12 months of age; 0.55 children and adolescent girls; and 0.70 adolescent boys. - Adult Population (age =18): Serum creatinine =1.0 mg/dL; if serum creatinine >1.0 mg/dL, then the estimated glomerular filtration rate (GFR) must be >60 mL/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease equation where Predicted GFR (ml/min/1.73 m2) = 186 x (Serum Creatinine)-1.154 x (age in years)-0.023 x (0.742 if patient is female) x (1.212 if patient is black. - Total bilirubin <1.5 x ULN for age and conjugated/direct serum bilirubin = ULN for age if total bilirubin is elevated. - Aspartate transaminase (AST)/alanine transaminase (ALT) = 2.5 × ULN. - Alkaline phosphatase = 2.5 × ULN. Exclusion Criteria: - Patients with Down Syndrome. - Prior treatment with Clofarabine. - Previous history of veno-occlusive disease (VOD) or findings consistent with a diagnosis of VOD, defined as: conjugated serum bilirubin > 1.4 mg/dL AND unexplained weight gain greater than 10% of baseline weight or ascites AND hepatomegaly or right upper quadrant pain without another explanation, OR reversal of portal vein flow on ultrasound, OR pathological confirmation of VOD on liver biopsy. - Patients who have a history of cirrhosis of the liver or who are positive for hepatitis B core antibody (anti-HBc) or have a positive test for hepatitis C antibody (anti-HCV). - Patient has received TBI. - If it has been less than 1 year since the patient had a HSCT. - Infection Criteria - Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment). - Positive blood culture within 48 hours of study registration. - Patient required supplemental oxygen or vasopressors within 48 hours of study (Oxygen after anesthesia for procedures is ok). - Patient is receiving or plans to receive concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol. - Use of investigational agents within 30 days or any anticancer therapy within 2 weeks before planned drug initiation with the exception of hydroxyurea or intrathecal therapy given with the diagnostic lumbar puncture. - Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo treatment. - Pregnant or lactating patients. - Any significant concurrent disease, illness, psychiatric disorder or social issue that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results. - Have had a diagnosis of another malignancy, unless the patient has been disease-free for at least 3 years following the completion of curative intent therapy with the following exceptions: - Patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed. - Patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate-specific antigen (PSA) values are also eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Children's Memorial | Chicago | Illinois |
| United States | Childrens Hospital Los Angeles | Los Angeles | California |
| United States | University of Miami Cancer Center | Miami | Florida |
| United States | Childrens Hospital & Clinics of Minnesota | Minneapolis | Minnesota |
| Lead Sponsor | Collaborator |
|---|---|
| Therapeutic Advances in Childhood Leukemia Consortium | Genzyme, a Sanofi Company |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Achievement of Complete Remission (CR) at Reinduction | Disease response assessed after chemotherapy from bone marrow aspirates/biopsies and complete blood count. | Between Days 22-36 or on Day 43 and weekly thereafter if peripheral counts haven't recovered | |
| Primary | Death | Number of participants who died. | From the first dose of study therapy until 30 days after last therapy dose |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT01743807 -
Phase I Study of GNKG168 in Acute Lymphoblastic Leukemia and Acute Myelogenous Leukemia
|
Phase 1 | |
| Completed |
NCT03081780 -
Open Label NK Cell Infusion (FATE-NK100) With Subq IL-2 in Adults With AML
|
Phase 1 |