LymphomaPhase 2NCT00669812
High-Dose Chemotherapy Given Together With Peripheral Blood Stem Cell Transplant in Treating Patients With Intestinal T-Cell Lymphoma
A Phase 2 study testing carmustine, cyclophosphamide and cytarabine in people with Lymphoma and Small Intestine Cancer, run by Cancer Research UK at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Small Intestine Cancer
- What is being tested?
- carmustine, cyclophosphamide and cytarabine
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2008to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
Newcastle upon Tyne, England, NE1 4LP
Anne Lennard, 44-191-282-4743, a.l.lennard@ncl.ac.uk
About this study
Official title: A Phase II Evaluation of High Dose Chemotherapy and Autologous Stem Cell Transplantation for Intestinal T-cell Lymphomas
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.
Read the 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.
- Conditions
- Lymphoma, Small Intestine Cancer
- Being tested
- carmustine, cyclophosphamide, cytarabine, doxorubicin hydrochloride, epirubicin hydrochloride
- 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
- Medical subject headings
- Lymphoma, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carmustineDrug
cyclophosphamideDrug
cytarabineDrug
epirubicin hydrochlorideDrug
etoposideDrug
ifosfamideDrug
melphalanDrug
methotrexateDrug
prednisoloneDrug
autologous hematopoietic stem cell transplantationProcedure or surgery
biopsyProcedure or surgery
peripheral blood stem cell transplantationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival at 1 year
Secondary outcomes (1)
Toxicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2008 (estimated)
- Study startFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Research UK
- Sponsor type
- University, hospital or other
- Investigators
- Anne Lennard, Principal investigator, Sir James Spence Institute of Child Health at Royal Victoria Infirmary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00669812
- Sponsor's protocol ID
- CDR0000593564
- Other IDs
- CRUK-2005-003906-27, CRUK-BRD/05/93
- Status last verified
- Nov 2008
- First submitted
- 30 Apr 2008
- Last updated
- 26 Aug 2013
- Results posted
- No
Publications
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.
PubMed 30104718
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Evaluation of High Dose Chemotherapy and Autologous Stem Cell Transplantation for Intestinal T-cell Lymphomas
- ClinicalTrials.gov ID
- NCT00669812
- Acronym / sponsor ID
- CDR0000593564
- Conditions
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cancer Research UKUniversity, hospital or other
- Study start
- Feb 2008
- First posted
- 1 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| carmustine | Drug | – |
| cyclophosphamide | Drug | – |
| cytarabine | Drug | – |
| doxorubicin hydrochloride | Drug | – |
| epirubicin hydrochloride | Drug | – |
| etoposide | Drug | – |
| ifosfamide | Drug | – |
| melphalan | Drug | – |
| methotrexate | Drug | – |
| prednisolone | Drug | – |
| vincristine sulfate | Drug | – |
| autologous hematopoietic stem cell transplantation | Procedure or surgery | – |
| biopsy | Procedure or surgery | – |
| peripheral blood stem cell transplantation | Procedure or surgery | – |
Primary outcome
Survival at 1 year
1 secondary outcome
Toxicity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2013.
- Derived from this study: PubMed 30104718Phillips 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
Newcastle upon Tyne, United Kingdom
Anne Lennard principal investigator
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing carmustine, cyclophosphamide and cytarabine in people with Lymphoma and Small Intestine Cancer, run by Cancer Research UK at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival at 1 year. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00669812, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2013.