Non Hodgkin LymphomaPhase 2NCT02507479
Thiotepa-based Conditioning for Allogeneic Stem-cell Transplantation (SCT) in Lymphoid Malignancies
A Phase 2 study testing Thiotepa in people with Non Hodgkin Lymphoma and Hodgkin Lymphoma, run by Sheba Medical Center at 2 sites in Israel.
Trial summary
The study hypotheses is that the introduction of dose escalated thiotepa, in substitution to busulfan or melphalan, will reduce toxicity after allogeneic transplantation while improving disease eradication in patients with lymphoid malignancies not eligible for standard transplantation. Read more about this study
- Who is it for?
- Ages 18 to 68 yearsHealthy volunteers can take part
- Conditions the study is for
- Non Hodgkin Lymphoma, Hodgkin Lymphoma, Chronic Lymphocytic Leukemia
- What is being tested?
- Thiotepa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesIsrael
- Study dates
- Sep 2015to Jul 2019
- 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 to 68 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age less than physiologic 68 years.
- Patients with MM, NHL, HL and CLL with an indication for allogeneic transplantation as follows:
- MM; patients relapsing after autologous transplant or with high-risk cytogenetic abnormalities
- Aggressive lymphoma and Hodgkin lymphoma; relapse after autologous transplants
- Follicular lymphoma; failure of at least one prior regimen
- CLL; failure of prior therapy which includes Fludarabine combinations or 17p- cytogenetic abnormality
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- Patients must have an HLA matched related or unrelated donor willing to donate either peripheral blood stem cells or bone marrow. Matching is based on high-resolution class I (HLA-A, -B, -C) and class II (HLA-DRB1, -DQB) typing. The goal is to transplant > 3 x 106 CD34+ cells per kg body weight of the recipient
- Patients must sign written informed consent.
- Adequate birth control in fertile patients.
Who cannot join
- Bilirubin > 3.0 mg/dl, transaminases > 3 times upper normal limit
- Creatinine > 2.0 mg/dl
- ECOG-Performance status > 2
- Uncontrolled infection
- Pregnancy or lactation
- Abnormal lung diffusion capacity (DLCO < 40% predicted)
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- Severe cardiovascular disease
- CNS disease involvement
- Pleural effusion or ascites > 1 liter
- Known hypersensitivity to Fludarabine or treosulfan
- Psychiatric conditions/disease that impair the ability to give informed consent or to adequately co-operate
Trial locations and contacts
2 sites in 1 country.
Israel2 sites, 2 recruiting
- Recruiting
Chaim Sheba Medical Center
Tel HaShomer, 52621
Arnon Nagler, MD, 972 3 530 5830, a.nagler@sheba.health.gov.il
Avichai Shimoni, MD, 972 3 530 5303, ashimoni@sheba.health.gov.il
- Recruiting
Chaim Sheba Medical Center
Tel HaShomer
Arnon Nagler, MD
About this study
Official title: Phase II Trial of Fludarabine Combined With Intravenous Thiotepa and Allogeneic Hematopoietic Stem-cell Transplantation in Patients With Lymphatic Malignancies Including Multiple Myeloma, Non Hodgkin's, Hodgkin Lymphoma and CLL
The study hypotheses is that the introduction of dose escalated thiotepa, in substitution to busulfan or melphalan, will reduce toxicity after allogeneic transplantation while improving disease eradication in patients with lymphoid malignancies not eligible for standard transplantation.
- Being tested
- Thiotepa
- Medical subject headings
- Lymphoma, Non-Hodgkin, Hodgkin Disease, Leukemia, Lymphocytic, Chronic, B-Cell, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThiotepaDrug
Chemotherapy given prior to allogeneic stem cell transplantation
| Study group | Role | What they receive |
|---|---|---|
| thiotepa | Experimental | Thiotepa 5-10 mg/kg/d x 2 days Receives: Drug: Thiotepa |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease-free survival
The percentage of patients alive without disease recurrence 2 years after transplant
Measured: 2 years after transplantation
Secondary outcomes (3)
treatment-related mortality
The percentage of patients who die of complications related to the transplant
Measured: 2 years after transplantation
graft versus host disease
The percentage of patients experiencing graft-versus-host disease after transplant
Measured: 1 year after transplantation
relapse
The percentage of patients experiencing disease recurrence after transplant
Measured: 2 years after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2015 (estimated)
- Study startSep 2015
- Primary completionJul 2017 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Hodgkin 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Arnon Nagler, MD, Principal investigator, Chaim Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02507479
- Sponsor's protocol ID
- SHEBA-13-0874-AN-CTIL
- Status last verified
- Apr 2016
- First submitted
- 14 Jun 2015
- Last updated
- 20 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Fludarabine Combined With Intravenous Thiotepa and Allogeneic Hematopoietic Stem-cell Transplantation in Patients With Lymphatic Malignancies Including Multiple Myeloma, Non Hodgkin's, Hodgkin Lymphoma and CLL
- ClinicalTrials.gov ID
- NCT02507479
- Acronym / sponsor ID
- SHEBA-13-0874-AN-CTIL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Sep 2015
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 24 Jul 2015 (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.
The study hypotheses is that the introduction of dose escalated thiotepa, in substitution to busulfan or melphalan, will reduce toxicity after allogeneic transplantation while improving disease eradication in patients with lymphoid malignancies not eligible for standard transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| thiotepa | Experimental | Drug: ThiotepaThiotepa 5-10 mg/kg/d x 2 days |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age less than physiologic 68 years.
- Patients with MM, NHL, HL and CLL with an indication for allogeneic transplantation as follows:
- Patients must have an HLA matched related or unrelated donor willing to donate either peripheral blood stem cells or bone marrow. Matching is based on high-resolution class I (HLA-A, -B, -C) and class II (HLA-DRB1, -DQB) typing. The goal is to transplant > 3 x 106 CD34+ cells per kg body weight of the recipient
- Patients must sign written informed consent.
- Adequate birth control in fertile patients.
Key exclusion criteria (11 listed)
- Bilirubin > 3.0 mg/dl, transaminases > 3 times upper normal limit
- Creatinine > 2.0 mg/dl
- ECOG-Performance status > 2
- Uncontrolled infection
- Pregnancy or lactation
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 |
|---|---|---|
| ThiotepaChemotherapy given prior to allogeneic stem cell transplantation | Drug | thiotepa |
Primary outcome
disease-free survival
Time frame: 2 years after transplantation
The percentage of patients alive without disease recurrence 2 years after transplant
3 secondary outcomes
treatment-related mortality
Time frame: 2 years after transplantation
graft versus host disease
Time frame: 1 year after transplantation
relapse
Time frame: 2 years after transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2016.
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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.
Arnon Nagler, MD principal investigator
Chaim Sheba Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Thiotepa in people with Non Hodgkin Lymphoma and Hodgkin Lymphoma, run by Sheba Medical Center at 2 sites in Israel.
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 9 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 20 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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?
Contact Avichai Shimoni, MD (972 3 530 5830, ashimoni@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease-free survival (time frame: 2 years after transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Apr 2016.