AzTrials
AzTrials

Mantle Cell LymphomaPhase 1/2NCT01484093

Sequential Chemo-Radioimmunotherapy Followed by Autologous Transplantation for Patients With Untreated Advanced Stage Mantle Cell Lymphoma

A Phase 1/2 study testing R-CHOP-14R-HIDAC,followed by RIT/HDT/ASCR. in people with Mantle Cell Lymphoma, run by Memorial Sloan Kettering Cancer Center at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Mantle cell lymphoma (MCL) is a rare and aggressive type of lymphoma, with only about 3,000 cases diagnosed per year. MCL is considered a difficult cancer to treat. This study is being done to better understand how to treat MCL. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Mantle Cell Lymphoma
What is being tested?
R-CHOP-14R-HIDAC,followed by RIT/HDT/ASCR.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
5 sitesUnited States
Study dates
29 Nov 2011to 11 Aug 2023
Phase
Phase 1/2
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Previously untreated advanced stage mantle cell lymphoma (Clinical stage 2 with abdominal involvement, stage 3 and stage 4).
  • Histologic diagnosis confirmed by MSKCC pathologist as mantle cell lymphoma with Cyclin D1, or D2 and/or, D3 staining performed. Presence of measurable disease as determined by FDG-PET, CT, endoscopy, colonoscopy, or bone marrow biopsy.
  • Ages 18-70.
  • Transplant eligibility as confirmed by the Disease Management Team.
  • KPS ≥ 70%.
  • Adequate organ function:
Show all 13Show fewer
  • WBC ANC ≥ 1000 cells/mcL and platelet count ≥ 100,000 cells/mcL unless felt to be secondary to underlying mantle cell lymphoma at which any count is permissible.
  • Adequate renal function as determined by Cr < or = to 1.5 mg/dL or 24 hr creatinine clearance ≥ 50 ml/hr
  • Adequate hepatic function as determined by total bilirubin < or = to 1.5x ULN (unless known Gilbert syndrome) and AST < or = to 5.0x ULN.
  • Cardiac ejection fraction greater than or equal to 50% as determined by echocardiogram or MUGA.
  • For patients ≥ age 60, a stress echocardiogram will be required, with same requirements as above.
  • DLCO greater than or equal to 50% as determined by pulmonary function tests performed prior to initiation of treatment.
  • Patients with positive Hepatitis B serologies will be treated per institutional guidelines.

Who cannot join

  • Prior treatment for mantle cell lymphoma, including more than 7 days of steroids, immunotherapy, radioimmunotherapy, or chemotherapy. This does not include patients who have initiated R-CHOP at an outside institution within 2 weeks of enrollment.
  • Patients using > or = to 10mg/day of steroids for any chronic medical condition
  • Pregnant or breast-feeding. Note: Pre-menopausal patients must have a negative, serum HCG within 14 days of enrollment,.
  • HIV positive or Hepatitis C antibody positive.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Memorial Sloan Kettering at Basking Ridge

    Basking Ridge, New Jersey, 07920

  • Memorial Sloan Kettering Cancer Center @ Suffolk

    Commack, New York, 11725

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Memorial Sloan Kettering at Mercy Medical Center

    Rockville Centre, New York

  • Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center

    Sleepy Hollow, New York, 10591

Other trials in United States

About this study

Official title: Sequential Chemo-Radioimmunotherapy Followed by Autologous Transplantation for Patients With Untreated Advanced Stage Mantle Cell Lymphoma: A Phase I/II Trial

Mantle cell lymphoma (MCL) is a rare and aggressive type of lymphoma, with only about 3,000 cases diagnosed per year. MCL is considered a difficult cancer to treat. This study is being done to better understand how to treat MCL.

Being tested
R-CHOP-14R-HIDAC,followed by RIT/HDT/ASCR.
Keywords
CYCLOPHOSPHAMIDE (CYTOXAN), CYTARABINE (ARA-C), DOXORUBICIN/ADRIAMYCIN, PREDNISONE, RITUXIMAB, TOSITUMOMAB (BEXXAR), Iodine, VINCRISTIN, Lymphoma, Chemo-Radioimmunotherapy, Autologous Transplantation, Untreated, 11-095
Medical subject headings
Lymphoma, Mantle-Cell, Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • R-CHOP-14R-HIDAC,followed by RIT/HDT/ASCR.Other

    Also called HIGH DOSE CHEMOTHERAPY AND AUTOLOGOUS STEM CELL RESCUE (ASCR)Patients admitted to the hospital for high dose chemotherapy. The anticipated length of, stay is 3-4 weeks. 14 days ± 1 day following the administration of the therapeutic dose of Iodine 131 I, Tositumomab, patients will be admitted for high-dose chemotherapy. BEAM, will be administered

    INDUCTION: R-CHOP-14 CHEMOTHERAPY: 4 cycles every 2 weeks ± 1 day All patients in the study in both phases will undergo induction and consolidation with R-CHOP 14R-HIDAC, followed by RIT/HDT/ASCR. Patients will undergo restaging scans 12 to 14 days following completion of R-CHOP 14, with CT, and FDG-PET. Patients demonstrating at least a PR may proceed to consolidation with R-HIDAC. CONSOLIDATION: R- HIDAC CHEMOTHERAPY: 2 cycles every 3 weeks ± 2 days After R-HIDAC, restaging will occur 17-21 days post cycle 2 with CT scan (or FDG-PET, if this was positive following R-CHOP-14). Radioimmunotherapy Dosimetric dose is given approximately 4-5 weeks after completing cycle 2 of R-HIDAC. This is to be preferred 1 week post restaging scans 17-21 days post cycle 2 of RHIDAC, and up to 2 weeks post-scans will be acceptable only if required by 131 I Tositumomab availability.

Study groups in NCT01484093
Study groupRoleWhat they receive
R-CHOP-14R-HIDAC,followed by RIT/HDT/ASCR.ExperimentalThis is a phase I/phase II multi-institution trial. The phase I part of the trial will determine the MTD of cytarabine. The phase II part of the trial will examine the efficacy of the proposed regimen by evaluating the 3-year event-free survival (EFS) in patients with untreated mantle cell lymphoma. All patients in the study in both phases will undergo induction and consolidation with R-CHOP 14R-HIDAC, followed by RIT/HDT/ASCR.
Receives: Other: R-CHOP-14R-HIDAC,followed by RIT/HDT/ASCR.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. maximum tolerated dose (MTD)

    of HIDAC. For this study the MTD will be the dose at which no more than one grade 3 CNS toxic event (defined by CTCAE 4.0 as severe neurologic symptoms limiting self care ADLs') up to two weeks following HIDAC occurs among a 6 patient cohort. Phase I

    Measured: 1 year

  2. 3 year Event Free Survival (EFS)

    from 67% (historical control) to 80 % in all patients. The EFS interval starts at enrollment date, and an event is defined as death from any cause or progression of disease. Patients who have completed the ASCT but elect to be removed from the study or lost to follow-up by the end of the third year will be counted as events as well. Phase II

    Measured: 3 years

Secondary outcomes (3)

  1. 3-year Event Free Survival (EFS)

    in subsets of patients with Ki-67 ≥ 30%

    Measured: 3 years

  2. rates of complete remission (CR)

    as defined by CT, FDG-PET and histology

    Measured: 1 year

  3. Determine 3 year overall survival (OS).

    Defined as last known follow up or date of death - date of diagnosis.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2011 (estimated)
  2. Study start29 Nov 2011
  3. Primary completion11 Aug 2023
  4. Study completion11 Aug 2023

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
96 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01484093
Sponsor's protocol ID
11-095
Status last verified
Aug 2023
First submitted
29 Nov 2011
Last updated
16 Aug 2023
Results posted
No

Publications

  • Kumar A, Bantilan KS, Jacob AP, Park A, Schoninger SF, Sauter C, Ulaner GA, Casulo C, Faham M, Kong KA, Grewal RK, Gerecitano J, Hamilton A, Hamlin P, Matasar M, Moskowitz CH, Noy A, Palomba ML, Portlock CS, Younes A, Willis T, Zelenetz AD. Noninvasive Monitoring of Mantle Cell Lymphoma by Immunoglobulin Gene Next-Generation Sequencing in a Phase 2 Study of Sequential Chemoradioimmunotherapy Followed by Autologous Stem-Cell Rescue. Clin Lymphoma Myeloma Leuk. 2021 Apr;21(4):230-237.e12. doi: 10.1016/j.clml.2020.09.007. Epub 2021 Jan 1.

    PubMed 33558202

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing R-CHOP-14R-HIDAC,followed by RIT/HDT/ASCR. in people with Mantle Cell Lymphoma, run by Memorial Sloan Kettering Cancer Center at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 4 exclusion criteria. 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: finished, as of the sponsor's last update on 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

maximum tolerated dose (MTD) (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT01484093, 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 16 Aug 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in