High-Dose Chemotherapy Given Together With Peripheral Blood Stem Cell Transplant in Treating Patients With Intestinal T-Cell Lymphoma
Primary Purpose
Lymphoma, Small Intestine Cancer
Status
Unknown status
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
carmustine
cyclophosphamide
cytarabine
doxorubicin hydrochloride
epirubicin hydrochloride
etoposide
ifosfamide
melphalan
methotrexate
prednisolone
vincristine sulfate
autologous hematopoietic stem cell transplantation
biopsy
peripheral blood stem cell transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring small intestine lymphoma, stage I adult T-cell leukemia/lymphoma, stage II adult T-cell leukemia/lymphoma, stage III adult T-cell leukemia/lymphoma, stage IV adult T-cell leukemia/lymphoma
Eligibility Criteria
DISEASE CHARACTERISTICS:
Newly confirmed diagnosis of intestinal T-cell lymphoma/ enteropathy-type T-cell lymphoma according to the following WHO classifications:
- Usual phenotype CD3-, CD7-positive; CD5-, CD4-, CD8-negative; or CD30-positive
- Complete surgical resection allowed
PATIENT CHARACTERISTICS:
- Unsupported neutrophils ≥ 1,500/mm^3 unless attributed to lymphomatous bone marrow infiltration
- Unsupported platelets ≥ 100,000/mm^3 unless attributed to lymphomatous bone marrow infiltration
- Creatinine clearance ≥ 50 mL/min
- Alkaline phosphatase ≤ 2.5 times upper limit of normal (ULN)
- Bilirubin ≤ 2.5 times ULN
- Left ventricular ejection fraction ≥ 50%
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for ≥ 1 month after completion of study treatment
- Patients with any serious concomitant medical or psychiatric condition that would preclude them tolerating the planned treatment should be entered into the registration study only
- No known hepatitis B, hepatitis C, or HIV positivity
- No active uncontrolled cardiovascular disease
- No abnormal EKG if there is a previous history of cardiac problems
- No other severe impairment of cardiac function
- No active malignancy within the past 5 years except cervical intraepithelial neoplasia or localized skin cancer
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Prior diagnostic or emergency surgical procedures allowed
- More than 5 years since prior treatment for malignancy
- No prior chemotherapy or radiotherapy for treatment of lymphoma
Sites / Locations
- Sir James Spence Institute of Child Health at Royal Victoria InfirmaryRecruiting
Outcomes
Primary Outcome Measures
Survival at 1 year
Secondary Outcome Measures
Toxicity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00669812
Brief Title
High-Dose Chemotherapy Given Together With Peripheral Blood Stem Cell Transplant in Treating Patients With Intestinal T-Cell Lymphoma
Official Title
A Phase II Evaluation of High Dose Chemotherapy and Autologous Stem Cell Transplantation for Intestinal T-cell Lymphomas
Study Type
Interventional
2. Study Status
Record Verification Date
November 2008
Overall Recruitment Status
Unknown status
Study Start Date
February 2008 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Cancer Research UK
4. Oversight
5. Study Description
Brief Summary
RATIONALE: Giving chemotherapy before a peripheral blood stem cell transplant stops the growth of cancer cells by stopping them from dividing or by killing them. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.
PURPOSE: This phase II trial is studying high-dose chemotherapy given together with peripheral blood stem cell transplant in treating patients with intestinal T-cell lymphoma.
Detailed Description
OBJECTIVES:
Primary
To assess the efficacy and toxicity of intensive high-dose chemotherapy (alternating I'VE regimen and intermediate-dose methotrexate) followed by autologous peripheral blood stem cell transplantation for treatment of patients with intestinal T-cell lymphoma.
Secondary
To assess the toxicity of the regimen in a large population of these patients.
To provide a coordinated approach to the treatment of these patients.
To register patients unfit for the protocol chemotherapy into the pathological part of the study.
OUTLINE: This is a multicenter study
Chemotherapy: Patients receive CHOP chemotherapy comprising cyclophosphamide IV over 15 minutes, doxorubicin hydrochloride IV, and vincristine IV on day 1. Patients also receive oral prednisolone on days 1-5.
After recovering from CHOP chemotherapy, patients receive I'VE chemotherapy comprising epirubicin hydrochloride IV on day 1 and etoposide IV over 2 hours and ifosfamide IV continuously on days 21-23. Patients also receive methotrexate IV over 24 hours on day 21. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.
Consolidation therapy: On day 77, stem cells are collected from patients if the marrow is clear of disease. After completion of chemotherapy, patients in complete remission receive carmustine IV on day 105, cytarabine IV and etoposide IV on days 106-109, and melphalan IV on day 110. These patients undergo autologous peripheral blood stem cell transplantation on day 112.
Prior to study treatment, patients undergo a biopsy of the gut to confirm diagnosis and a blood sample is taken. Both blood and tissue samples may be used for further studies.
After recovery from treatment, patients are followed monthly for 4 months, then bimonthly for 1 year, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Small Intestine Cancer
Keywords
small intestine lymphoma, stage I adult T-cell leukemia/lymphoma, stage II adult T-cell leukemia/lymphoma, stage III adult T-cell leukemia/lymphoma, stage IV adult T-cell leukemia/lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
carmustine
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
cytarabine
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
epirubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
etoposide
Intervention Type
Drug
Intervention Name(s)
ifosfamide
Intervention Type
Drug
Intervention Name(s)
melphalan
Intervention Type
Drug
Intervention Name(s)
methotrexate
Intervention Type
Drug
Intervention Name(s)
prednisolone
Intervention Type
Drug
Intervention Name(s)
vincristine sulfate
Intervention Type
Procedure
Intervention Name(s)
autologous hematopoietic stem cell transplantation
Intervention Type
Procedure
Intervention Name(s)
biopsy
Intervention Type
Procedure
Intervention Name(s)
peripheral blood stem cell transplantation
Primary Outcome Measure Information:
Title
Survival at 1 year
Secondary Outcome Measure Information:
Title
Toxicity
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Newly confirmed diagnosis of intestinal T-cell lymphoma/ enteropathy-type T-cell lymphoma according to the following WHO classifications:
Usual phenotype CD3-, CD7-positive; CD5-, CD4-, CD8-negative; or CD30-positive
Complete surgical resection allowed
PATIENT CHARACTERISTICS:
Unsupported neutrophils ≥ 1,500/mm^3 unless attributed to lymphomatous bone marrow infiltration
Unsupported platelets ≥ 100,000/mm^3 unless attributed to lymphomatous bone marrow infiltration
Creatinine clearance ≥ 50 mL/min
Alkaline phosphatase ≤ 2.5 times upper limit of normal (ULN)
Bilirubin ≤ 2.5 times ULN
Left ventricular ejection fraction ≥ 50%
Not pregnant or nursing
Fertile patients must use effective contraception during and for ≥ 1 month after completion of study treatment
Patients with any serious concomitant medical or psychiatric condition that would preclude them tolerating the planned treatment should be entered into the registration study only
No known hepatitis B, hepatitis C, or HIV positivity
No active uncontrolled cardiovascular disease
No abnormal EKG if there is a previous history of cardiac problems
No other severe impairment of cardiac function
No active malignancy within the past 5 years except cervical intraepithelial neoplasia or localized skin cancer
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
Prior diagnostic or emergency surgical procedures allowed
More than 5 years since prior treatment for malignancy
No prior chemotherapy or radiotherapy for treatment of lymphoma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Lennard
Organizational Affiliation
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
City
Newcastle-Upon-Tyne
State/Province
England
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Lennard
Phone
44-191-282-4743
Email
a.l.lennard@ncl.ac.uk
12. IPD Sharing Statement
Citations:
PubMed Identifier
30104718
Citation
Phillips EH, Lannon MM, Lopes A, Chadwick H, Jones G, Sieniawski M, Davies A, Wood K, Clifton-Hadley L, Smith P, Lawrie A, Chadwick N, Lennard AL. High-dose chemotherapy and autologous stem cell transplantation in enteropathy-associated and other aggressive T-cell lymphomas: a UK NCRI/Cancer Research UK Phase II Study. Bone Marrow Transplant. 2019 Mar;54(3):465-468. doi: 10.1038/s41409-018-0294-2. Epub 2018 Aug 13. No abstract available. Erratum In: Bone Marrow Transplant. 2019 Mar 12;:
Results Reference
derived
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High-Dose Chemotherapy Given Together With Peripheral Blood Stem Cell Transplant in Treating Patients With Intestinal T-Cell Lymphoma
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