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Acute Myeloid LeukemiaPhase 1/2NCT02310243

Study of Palbociclib in MLL-rearranged Acute Leukemias

A Phase 1/2 study testing Palbociclib in people with Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, run by University of Ulm at 24 sites in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Diagnosis: Acute myeloid leukemia; Acute lymphoblastic leukemia Age ≥ 18 years, no upper age limit Study drug: Palbociclib Phase Ib/IIa, open-label Phase Ib: Based on previous experience with 125 mg palbociclib once daily for 21 days followed by 7 days of rest in patients with breast cancer, liposarcoma, non-small… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Palbociclib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
24 sitesGermany
Study dates
Jul 2015to Jul 2019
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with confirmed diagnosis of acute leukemia with MLL rearrangement according to the 2008 WHO Classification
  • Patients with MLL-rearranged leukemia who are refractory to standard induction therapy and not immediate candidates for allogeneic HSCT (bridge to transplant is allowed)
  • Patients with MLL-rearranged leukemia who relapsed after standard first-line treatment and are not immediate candidates for allogeneic HSCT (bridge to transplant is allowed)
  • Patients with newly diagnosed MLL-rearranged leukemia who are not eligible for intensive first-line therapy
  • Genetic/histologic/immunohistologic assessment in one of the central laboratories
  • Age ≥ 18 years, no upper age limit
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  • WHO performance status of ≤ 2
  • No prior chemotherapy two weeks before study entry except hydroxyurea to control hyperleukocytosis
  • Non-pregnant and non-nursing. Women of child-bearing potential must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 72 hours prior to registration (WOCBP is defined as a sexually active mature woman who has not undergone a hysterectomy or who has had menses at any time in the preceding 24 months).
  • Female patients in the reproductive age and male patients must agree to avoid getting pregnant or to father a child while on therapy and for three months after the last dose of therapy.
  • Women of child-bearing potential must either commit to continued abstinence from heterosexual intercourse or begin one acceptable method of birth control (IUD, tubal ligation, or partner's vasectomy). Hormonal contraception is an inadequate method of birth control.
  • Men must agree not to father a child and must use a latex condom during any sexual contact with WOCBP while receiving therapy and for three months after therapy is stopped, even if they have undergone successful vasectomy.
  • Signed written informed consent

Who cannot join

  • Prior treatment with palbociclib
  • Performance status > 2 according to WHO criteria
  • Organ insufficiency: creatinine > 1.5 x upper normal serum level; bilirubin, AST, or AP > 2.5 x upper normal serum level; heart failure NYHA III/IV; uncontrolled hypertension; unstable angina; serious cardiac arrhythmia; severe obstructive or restrictive ventilation disorder
  • Uncontrolled infection
  • Patients with a "currently active" second malignancy other than non-melanoma skin cancer. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse within one year.
  • Severe neurologic or psychiatric disorder interfering with ability of giving informed consent
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  • Known or suspected active alcohol or drug abuse
  • Known positivity for HIV, active HAV, HBV, or HCV infection
  • Bleeding disorder unrelated to leukemia
  • Uncontrolled CNS involvement (treatment for CNS-involvement prior to inclusion is allowed)
  • QTc > 470 msec (based on the mean value of triplicate ECGs), family or personal history of long or short QT syndrome, Brugada syndrome, or known history of QTc prolongation or Torsade de Pointes
  • Uncontrolled electrolyte disorders that can aggravate the effects of a QTc-prolonging drug (e.g., hypocalcemia, hypokalemia, hypomagnesemia)
  • No consent for registration, storage, and processing of individual disease characteristics, information on the course of the disease, and information obtained from the family physician and/or other physicians involved in the treatment of the patient about study participation
  • No consent for biobanking

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

Germany24 sites, 24 recruiting

  • Klinikum Augsburg

    Augsburg, 86156

    Christoph Schmid, MD, christoph.schmid@klinikum-augsburg.de

    Recruiting

  • Helios Klinikum Bad Saarow

    Bad Saarow, 15526

    Daniel Schöndube, MD, daniel.schoendube@helios-kliniken.de

    Recruiting

  • Charité Campus Benjamin Franklin

    Berlin, 12200

    Claudia Bladus, MD, claudia.baldus@charite.de

    Recruiting

  • Vivantes Klinikum Neukölln

    Berlin, 12351

    Maike de Wit, MD, maike.dewit@vivantes.de

    Recruiting

  • Charité Campus Virchow-Klinikum

    Berlin, 13353

    Jörg Westermann, MD, joerg.westermann@charite.de

    Recruiting

  • Universitätsklinikum Bonn

    Bonn, 53105

    Karin Tina Mayer, MD, karin.mayer@ukb.uni-bonn.de

    Recruiting

  • Städtisches Klinikum Braunschweig gGmbH

    Braunschweig, 38114

    Jürgen Krauter, MD, krauter.juergen@mh-hannover.de

    Recruiting

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40225

    Thomas Schroeder, MD, thomas.schroeder@med.uni-duesseldorf.de

    Recruiting

  • Kliniken Essen Süd, Ev. Krankenhaus Essen-Werden gGmbH

    Essen, 45239

    Mohammed Wattad, MD, m.wattad@kliniken-essen-sued.de

    Recruiting

  • Malteser Krankenhaus St. Franziskus-Hospital

    Flensburg, 24939

    Nadezda Basara, MD, nadezda.basara@malteser.org

    Recruiting

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 791016

    Ralph Wäsch, MD, ralph.waesch@uniklinik-freiburg.de

    Recruiting

  • MVZ Osthessen

    Fulda, 36043

    Andrea Distelrath, MD, distelrath@mvz-osthessen.de

    Recruiting

  • Universitätsklinikum Giessen

    Giessen, 35392

    Maisun Abu Samara, MD, maisun.abu.samra@innere.med.uni-giessen.de

    Recruiting

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246

    Walter Fiedler, MD, fiedler@uke.de

    Recruiting

  • Medizinische Hochschule Hannover

    Hanover, 30625

    Michael Heuser, MD, heuser.michael@mh-hannover.de

    Recruiting

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120

    Alwin Krämer, MD, Alwin.Kraemer@med.uni-heidelberg.de

    Recruiting

  • Städtisches Klinikum Karlsruhe gGmbH

    Karlsruhe, 76133

    Mark Ringhoffer, MD, mark.ringhoffer@klinikum-karlsruhe.com

    Recruiting

  • Universitätsklinikum Schleswig-Holstein Campus Kiel

    Kiel, 24116

    Heinz-August Horst, MD, h.horst@med2.uni-kiel.de

    Recruiting

  • Caritas-Krankenhaus Lebach

    Lebach, 66822

    Stephan Kremers, MD, stephankremers@onkologie-lebach.de

    Recruiting

  • Uni-Klinikum der Otto-von-Guericke-Universität

    Magdeburg, 39120

    Denise Wolleschak, MD, denise.wolleschak@med.ovgu.de

    Recruiting

  • Universitätsmedizin der Johannes Gutenberg-Universität

    Mainz, 55131

    Thomas Kindler, MD, thomas.kindler@unimedizin-mainz.de

    Recruiting

  • Pius Hospital Oldenburg

    Oldenburg, 26121

    Frank Griesinger, MD, frank.griesinger@pius-hospital.de

    Recruiting

  • Medizinische Universitätsklinik Tübingen

    Tübingen, 72076

    Helmut Salih, MD, Helmut.Salih@med.uni-tuebingen.de

    Recruiting

  • University Hospital of Ulm

    Ulm, 89081

    Peter Paschka, MD, 0049-731-500 ext. 45521, peter.paschka@uniklinik-ulm.de

    Recruiting

Other trials in Germany

About this study

Official title: Phase Ib/IIa Study of Palbociclib in MLL-rearranged Acute Leukemias AMLSG 23-14/Palbo-AL-1

Diagnosis: Acute myeloid leukemia; Acute lymphoblastic leukemia Age ≥ 18 years, no upper age limit Study drug: Palbociclib Phase Ib/IIa, open-label

  • Phase Ib: Based on previous experience with 125 mg palbociclib once daily for 21 days followed by 7 days of rest in patients with breast cancer, liposarcoma, non-small cell lung cancer, hepatocellular carcinoma, ovarian cancer, mantle-cell lymphoma, and glioblastoma, this regimen will be chosen for the first dose to be evaluated in the phase Ib. Based on a 3 + 3 modified Fibonacci design, the tolerable dose of palbociclib for the phase IIa is defined.
  • Phase IIa: single-agent palbociclib using the tolerable dose defined in the phase Ib part of the study is administered once daily for 21 days followed by 7 days of rest. Based on the optimal two-stage design of Simon, 21 patients are treated in the first stage. If results are positive, 29 additional patients will be recruited into the second stage of the study. An efficacy of the investigational therapy will be rejected in the first stage of 21 treated patients if two or less patients achieve complete remission (CR), CR with incomplete blood count recovery (CRi), partial remission (PR), or anti-leukemic effect (ALE). If three or more patients achieve CR, CRi, PR, or ALE during this first stage, the trial is intended to be continued in the second stage with a total sample size of 50 patients.
Read more

Start of recruitment: July 2015 End of recruitment: July 2017 End of study (last patient out): July 2018 The treatment duration of an individual patient is estimated to be 2-6 months, but may be unlimited in patients with sustained response ("case-by-case decision").

Observation time per patient after entry into the study (incl. treatment) is at least 12 months.

Being tested
Palbociclib
Keywords
Acute myeloid leukemia, Acute lymphoblastic leukemia, MLL-rearranged leukemia, Palbociclib (PD-0332991-00)
Medical subject headings
Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

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

  • PalbociclibDrug

    Also called PD-0332991-00

    oral, once daily (125mg, 100mg or 75mg) for 21 days

Study groups in NCT02310243
Study groupRoleWhat they receive
PalbociclibExperimentalPhase1b: 125 mg palbociclib once daily for 21 days followed by 7 days of rest; this regimen will be chosen for the first dose to be evaluated. phase IIa: single-agent palbociclib using the tolerable dose defined in the phase Ib part of the study is administered once daily for 21 days followed by 7 days of rest.
Receives: Drug: Palbociclib

What is being measured

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

  1. Number of Participants with Adverse Events

    Safety assessments

    Measured: 12 months

  2. Maximum tolerated dose of palbociclib

    Measured: 12 months

  3. overall response rate

    Measured: 12 months

Secondary outcomes (4)

  1. Relapse-free survival

    Measured: three years

  2. Overall survival

    Measured: three years

  3. Evaluation of target (CDK6) inhibition by palbociclib

    Measured: three years

  4. Assessment of Quality of life

    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 posted8 Dec 2014 (estimated)
  2. Study startJul 2015
  3. Primary completionJul 2019 (estimated)
  4. Study completionJul 2019 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02310243
Sponsor's protocol ID
AMLSG 23-14
Status last verified
Apr 2019
First submitted
1 Dec 2014
Last updated
16 Apr 2019
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Palbociclib in people with Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, run by University of Ulm at 24 sites in Germany.

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 14 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 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in Germany. 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?

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?

Number of Participants with Adverse Events (time frame: 12 months). The study lists 3 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 NCT02310243.

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 Apr 2019.

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