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Transplant-Related Hematologic MalignancyPhase 1NCT01751243

Transplantation of Hematopoietic Progenitors From Haploidentical Donor With Selective in Vitro Depletion Allo-reactive Lymphocytes in Patient With High Risk Hematological Malignancies

A Phase 1 study testing Allo-depleted lymphocyte infusion and Haploidentical transplantation of hematopoietic progenitors in people with Transplant-Related Hematologic Malignancy, run by Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud at 4 sites in Spain.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Therapeutic exploratory study to evaluate safety, open, nonrandomized, multicentre, prospective, of cohort of patients who will receive different doses of allo-depleted lymphocytes . Read more about this study

Who is it for?
Ages 16 to 50 years
What is being tested?
Allo-depleted lymphocyte infusion and Haploidentical transplantation of hematopoietic progenitors
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
4 sitesSpain
Study dates
Jan 2013to Dec 2018
Phase
Phase 1
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 16 to 50 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Adult patients aged between 16 and 50 years.
  • Diagnosed as Hematological malignancy candidates to allogeneic transplant lacking of related or unrelated suitable donor (is more than one Human leukocyte antigen (HLA) mismatched over 8 antigens) and who don't have a cord with an adequate cellularity. The minimum period of search to be able to include the patient in the trial, currently considering the medium to find a suitable donor to be 2 months, it is set to 10 weeks, although in specific situations in which the responsible physician considers that the patient has a high risk of relapse, it may be proceed with inclusion before that period. These cases will be assessed individually with the trial coordinator.

Who cannot join

  • General condition> Eastern Cooperative Oncology Group (ECOG) scale 2.
  • Left Ventricular ejection fraction (LVEF) <39%.
  • Diffusion capacity of lung for carbon monoxide (DLCO) and forced vital capacity (FVC) <39% of the theoretical values.
  • Impaired liver function (total bilirubin higher than 2 mg / dL and / or transaminases higher than 3 times the normal maximum.
  • Creatinine clearance <50 mL / minute.
  • Presence of symptomatic heart, liver cirrhosis or chronic active hepatitis.
Show all 11Show fewer
  • Active tuberculosis.
  • Serious diseases which prevent chemotherapy treatments.
  • Associated neoplasias (active neoplasias which, according to the opinion of the investigator and the sponsor, could jeopardize patient safety).
  • Presence of associated psychiatric pathology.
  • HIV infection.

Trial locations and contacts

4 sites in 1 country.

Spain4 sites

  • University Hospital Reina Sofia

    Córdoba, 14004

  • University Hospital Carlos Haya

    Málaga, 29010

  • University Hospital de Salamanca

    Salamanca, 37007

  • University Hospital Virgen del Rocío

    Seville, 41013

Other trials in Spain

About this study

Official title: Transplantation of Hematopoietic Progenitors From Haploidentical Donor With Selective in Vitro Depletion Allo-reactive Lymphocytes in Patient With High Risk Hematological Malignancies.

Therapeutic exploratory study to evaluate safety, open, nonrandomized, multicentre, prospective, of cohort of patients who will receive different doses of allo-depleted lymphocytes .

This project joins in this pioneering worldwide initiative with its own technology based on the use of proteasome inhibitors in vitro, which advantages are, over other methods described, the continuing viability of regulatory T cells and the use of a product to generate allo-depletion that, contrary to those reported by other research groups, it does not pose problems from the point of view of its use or toxicity as we employ a drug widely used clinically by intravenous administration.

Read the detailed description

The main objective of the study is to determine the safety of transplantation of hematopoietic progenitors from haploidentical donor with in vitro allo-depleted lymphocyte infusion.

Secondary objectives:

  • To assess the immune reconstitution pre and post-infusion of allo-depleted lymphocytes.
  • To analyze the incidence of infections (CMV and aspergillus) post-transplant.
  • To analyze the impact of acute and chronic graft-versus-host disease (GVHD).
  • To optimize the dose of allo-depleted lymphocytes to reconstitute an immune response against pathogens without causing GVHD.
  • To assess the rate of graft and myeloid and platelet engraftment time.
  • To assess the rate of relapses, event-free survival and overall survival. It is hoped to recruit 20 clinically evaluable patients for safety purpose.

The inclusion period is not more than 2 ½ years. Study duration shall not exceed three years from the inclusion of the first patient. The minimum follow-up of patients is 6 months after transplantation.

The first 5 patients (group 0) will receive haploidentical transplantation of hematopoietic progenitors without subsequent infusion of allo-depleted lymphocytes and then in cohorts of 3 patients, infuse +4 post-transplant day at doses of: 1x105 cluster of differentiation 3 (CD3)/kg(group 1), 3x105 CD3/kg (group 2), 5x105 CD3 / kg (group 3), 1x106 CD3/kg (group 4) and 3x106 CD3/kg (group 5).

Donor: it is performed one leukapheresis at least 30 days (4 weeks) prior to the scheduled progenitors infusion (day 0), in order to obtain effector T cells.

Being tested
Allo-depleted lymphocyte infusion, Haploidentical transplantation of hematopoietic progenitors

What participants receive

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

  • Allo-depleted lymphocyte infusionOther

    Doses: 1x105 CD3/Kg; 3x105 CD3/Kg; 5x105 CD3/Kg; 1x106 CD3/Kg;31x106 CD3/Kg;

  • Haploidentical transplantation of hematopoietic progenitorsOther

    Haploidentical transplantation of hematopoietic progenitors without subsequent infusion of allo-depleted lymphocytes.

Study groups in NCT01751243
Study groupRoleWhat they receive
Group 0Placebo comparatorHaploidentical transplantation of hematopoietic progenitors
Receives: Other: Haploidentical transplantation of hematopoietic progenitors
Group 1ExperimentalAllo-depleted lymphocyte infusion dose: 1x105 CD3/Kg
Receives: Other: Allo-depleted lymphocyte infusion
Group 2ExperimentalAllo-depleted lymphocyte infusion dose: 3x105 CD3/Kg
Receives: Other: Allo-depleted lymphocyte infusion
Group 3ExperimentalAllo-depleted lymphocyte infusion dose: 5x105 CD3/Kg
Receives: Other: Allo-depleted lymphocyte infusion
Group 4ExperimentalAllo-depleted lymphocyte infusion dose: 1x106 CD3/Kg
Receives: Other: Allo-depleted lymphocyte infusion
Group 5ExperimentalAllo-depleted lymphocyte infusion dose: 3x106 CD3/Kg
Receives: Other: Allo-depleted lymphocyte infusion

What is being measured

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

  1. Number of adverse events and serious adverse events after allo-depleted lymphocyte infusion in vitro.

    Measured: 6 months

Secondary outcomes (1)

  1. Incidence of acute and chronic GVHD

    Measured: 6 months

Timeline

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

  1. First posted17 Dec 2012 (estimated)
  2. Study startJan 2013
  3. Primary completionDec 2018 (estimated)
  4. Study completionDec 2018 (estimated)

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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01751243
Sponsor's protocol ID
ALODEPLETE
Status last verified
Sep 2017
First submitted
13 Dec 2012
Last updated
6 Jul 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Allo-depleted lymphocyte infusion and Haploidentical transplantation of hematopoietic progenitors in people with Transplant-Related Hematologic Malignancy, run by Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud at 4 sites in Spain.

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 2 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: withdrawn, as of the sponsor's last update on 6 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Spain. 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. Some participants in this study may receive a placebo. 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 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.

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 was withdrawn before enrolling participants, so there are no results.

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?

Number of adverse events and serious adverse events after allo-depleted lymphocyte infusion in vitro. (time frame: 6 months). 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 NCT01751243.

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 6 Jul 2018.

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