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Trial Title:
CalPeg for Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)
NCT ID:
NCT05581030
Condition:
Acute Lymphoblastic Leukemia
Conditions: Official terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Rituximab
Conditions: Keywords:
A.L.L.
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Hyper CVAD Protocol (Standard of Care Multi-Agent Chemotherapy)
Description:
Hyper-CVAD consists of two combinations of drugs (courses A and B) given in an
alternating fashion. The term "hyper" refers to the hyperfractionated nature of the
chemotherapy, which is given in small doses, more frequently, to minimize side effects.
CVAD is the acronym of the drugs in course a: cyclophosphamide, vincristine, doxorubicin
and dexamethasone.
Course A: Cyclophosphamide days 1, 2 and 3. Vincristine days 4 and 11, Doxorubicin day 4,
dexamethasone days 1-4 and 11-14, Cytarabine day 7. Mesna is also given orally with
cyclophosphamide, to reduce the incidence of haemorrhagic cystitis, a common side effect
of cyclophosphamide. Methotrexate, an antimetabolite, may be given when necessary to get
chemotherapy past the blood brain barrier.
Course B: Methotrexate Day 1 and Cytarabine Days 2 and 3. Dosage is individualized to the
patient.
Arm group label:
Hyper-CVAD + Calaspargase pegol Treatment
Intervention type:
Drug
Intervention name:
Calaspargase Pegol
Description:
Calaspargase pegol 2000 IU/m^2 (capped at 3750 IU) will be administered beginning in
cycle 1B of Hyper-CVAD, and will continue at this dose for the duration of the trial.
Arm group label:
Hyper-CVAD + Calaspargase pegol Treatment
Other name:
Asparlas
Other name:
CalPeg
Intervention type:
Drug
Intervention name:
Rituximab
Description:
Rituximab 375mg/m^2 will be administered once per cycle for patients with CD20+ ALL.
Arm group label:
Hyper-CVAD + Calaspargase pegol Treatment
Other name:
Rituxan
Summary:
The purpose of the study is to evaluate the safety and tolerability of the study drug,
calaspargase pegol, when given with multi-agent chemotherapy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Pathologically confirmed Philadelphia negative B- or T-cell acute lymphoblastic
leukemia, with >10% peripheral blood or bone marrow lymphoblasts at diagnosis.
- Treatment and full recovery from arm 1A of the Hyper-CVAD regimen.
- Be willing and able to provide written informed consent/assent for the trial.
- Able to adhere to the study visit schedule and other protocol requirements.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Cardiac ejection fraction ≥ 50% by echocardiography or MUGA, as measured prior to
arm 1A of Hyper-CVAD.
- Serum bilirubin and creatinine < 1.5x upper limit of normal (ULN). AST and ALT must
be <3x ULN.
- Females of childbearing potential (FCBP) must have a negative serum pregnancy test
at screening. A FCBP is considered when a sexually mature female: 1) has not
undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally
postmenopausal for at least 12 consecutive months.
- A FCBP must agree to use of two methods of highly effective non-hormonal
contraception, be surgically sterile, or abstain from heterosexual activity for the
course of the study through 3 monthsafter the last dose of study treatment.
- Male subjects must agree to use an adequate method of contraception starting with
the first dose of study therapy through 30 days after the last dose of study
therapy. Men must agree to not donate sperm during and after the study for 3 months
Exclusion Criteria:
- Induction therapy with any regimen other than Hyper-CVAD 1A.
- Diagnosis of L3 type Burkitt's lymphoma
- Clinical evidence of active central nervous system (CNS) leukemia.
- Any major surgery or radiation therapy within four weeks.
- Diagnosis of Down Syndrome.
- Any active infection requiring systemic therapy, including HIV, Hepatitis B, and/or
Hepatitis C.
- Has a history or current evidence of any condition, therapy, or laboratory
abnormality that might confound the results of the trial, interfere with the
subject's participation for the full duration of the trial, or is not in the best
interest of the subject to participate, in the opinion of the treating investigator
(including but not limited to unstable angina, pre-existing liver disease, recurrent
pancreatitis, uncontrolled diabetes, hypertriglyceridemia, pulmonary hypertension,
or severeheart failure (New York Heart Association Class III-IV).
- Recurrent thrombosis, or non-central venous catheter associated thrombosis within 3
months prior to enrollment.
- Severe comorbid conditions for which life expectancy would be <6 months.
- Patients with active (uncontrolled, metastatic) second malignancies are excluded.
- Is pregnant, breastfeeding, or expecting to conceive or father children within the
projected duration of the trial, starting with the screening visit through 3 months
after the last dose of trial treatment.
Gender:
All
Minimum age:
18 Years
Maximum age:
50 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Moffitt Cancer Center
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Recruiting
Contact:
Last name:
Waleed Kelada
Phone:
813-745-4673
Email:
Waleed.Kelada@moffitt.org
Investigator:
Last name:
Bijal Shah, MD
Email:
Principal Investigator
Investigator:
Last name:
Julio Chavez, MD, MS
Email:
Sub-Investigator
Investigator:
Last name:
Sameh Gaballa, MD
Email:
Sub-Investigator
Investigator:
Last name:
Leidy Isenalumhe, MD, MS
Email:
Sub-Investigator
Investigator:
Last name:
Hayder Saeed, MD
Email:
Sub-Investigator
Investigator:
Last name:
Lubomir Sokol, MD, PhD
Email:
Sub-Investigator
Start date:
May 1, 2023
Completion date:
May 2027
Lead sponsor:
Agency:
H. Lee Moffitt Cancer Center and Research Institute
Agency class:
Other
Collaborator:
Agency:
Servier
Agency class:
Industry
Source:
H. Lee Moffitt Cancer Center and Research Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05581030
